United States 
Industry Consensus Standard for the 
Uniform Labeling of 
Blood and Blood Components 
Using ISBT 128 
 
 
 
Version 3.0.0  
March 2013 
Tracking Number ICCBBA IG-002 
 
 
 
 
 
 
 
 
Published by: 
ICCBBA 
PO Box 11309, San Bernardino, CA  92423 USA 
 
 
Telephone: +1 (909)793-6516    Fax: +1 (909) 793-6214 
E-mail: iccbba@iccbba.org    Website: www.iccbba.org 
  US Consensus Standard, Version 3.0.0      1 
Acknowledgement 
 
ICCBBA thanks the members of the Americas Technical Advisory Group (ATAG) for their 
contributions in the development of this consensus standard. 
 
Members of ATAG 
Suzy Grabowski, Chair 
Suzanne Butch 
Guilherme Genovez 
Donald Gironne 
Sharon McMillan 
Dan Simpson 
 
Representatives 
Karen Burns, Veterans Administration 
Nikki Denlinger, American Red Cross 
Peggy Dunn, AABB 
Simon Fournier, HemaQuebec 
Lora Poore, Americas Blood Centers 
Dorothy Ward, Canadian Blood Services 
 
Liaisons 
Francisca Agbanyo, Health Canada 
Jennifer Jones, FDA 
 
Additionally, ICCBBA thanks the many observers who routinely participate in ATAG and provide 
valuable input. 
 
For reviewing and proof reading this document, ICCBBA thanks 
Jessica Youngblood, Oklahoma Blood Institute 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      2 
 
 
Editor 
 
Pat Distler, MS, MT(ASCP)SBB 
Technical Director, ICCBBA  
 
   
Standards Committee 
 
John Armitage, Prof., BSc, PhD  United Kingdom 
Paul Ashford, MSc. CEng. CSci.       ICCBBA 
Wayne Bolton, B.App.Sc., M.App.Sc   Australia 
Suzanne Butch, MA, MT(ASCP)SBB  United States of America 
Pat Distler, MS, MT(ASCP)SBB  ICCBBA 
Jrgen Georgsen, MD  Denmark 
Suzy Grabowski, BA, BB(ASCP)SBB  United States of America 
Mario Muon, MD  Portugal 
Stefan Poniatowski, BSc, MIBMS  Australia 
Leigh Sims Poston, BS, MT(ASCP)  United States of America 
Ineke Slaper-Cortenbach, PhD  The Netherlands 
Izabela Uhrynowska-Tyszkiewicz, MD, PhD  Poland 
Ruth Warwick, MB ChB  United Kingdom 
Diane Wilson, BSN, MSN/MHA  United States of America 
 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      3 
 
 
 
Warranty 
ICCBBA provides no warranty that the use of ISBT 128 is suitable for any particular purpose and the 
selection, use, efficiency, and suitability of ISBT 128 is the sole responsibility of the Licensed User. 
 
There are no guarantees or warranties attached to this Standard other than that ICCBBA agrees to 
furnish registered and licensed end-users with the most up-to-date information available. Successful 
implementation of this Standard, and use of any accompanying database table(s), depend(s) upon the 
correct incorporation of the rules and table contents into the software used by or provided to the 
registered and licensed facility. ICCBBA makes no other warranties of any kind, whether expressed or 
implied, including any implied warranty of merchantability or fitness for any particular purpose. Further 
information can be found at www.iccbba.org. 
 
Liability 
ICCBBAs liability is limited to that specified in the ICCBBA License Agreement which is available on the 
ICCBBA Website. Under  
no circumstances shall ICCBBAs liability exceed the current annual license fee, and ICCBBA will in no 
circumstances be liable for any damages whatsoever, including without limitation damages for loss of 
data, business or goodwill, or any other consequential losses of any nature arising from the use of ISBT 
128. 
 
ICCBBA manages the ISBT 128 Standard. ICCBBA is not an accrediting organization and is not 
responsible for adherence to the standard, the selection of Product Codes, or product labeling by 
facilities registered for its use. 
 
COPYRIGHT NOTICE AND LICENSING INFORMATION 
ISBT 128 is not in the public domain and is protected by law. Implementation of ISBT 128 requires the 
end-user to register with ICCBBA and to pay an annual license fee. License fees are established by the 
ICCBBA Board of Directors to cover the expenses of maintaining and extending ISBT 128, and making 
available current versions of the documents and database tables that are needed to implement this 
Standard. 
 
This Standard is intended for the use of those implementing ISBT 128, regulatory agencies, and software 
developers and other manufacturers that support end-users. 
 
Although it is made available to anyone wishing to obtain a copy, national Guidelines describing its use 
in a particular country may be an additional source of information for the end-user. If such Guidelines 
exist, they must be consulted because there are options in ISBT 128, and country-specific information 
pertaining to the particular use of such options will only be found in such Guidelines. 
 
Any use of the ISBT 128 Standard, its database tables, by other than registered and licensed facilities, or 
facilities that have obtained their computer software from a registered and licensed developer, is strictly 
forbidden. Copying any portion of the ISBT 128 Standard, or of its database tables, either in electronic or 
other format, without express written permission from ICCBBA is strictly forbidden. Posting of any portion 
of the ISBT 128 Standard, or of its database table, to any online service by anyone other than ICCBBA or 
the US Food and Drug Administration (FDA) is strictly forbidden. 
 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      4 
 
Table of Contents 
 
Abbreviations and Acronyms ...................................................................................................... 9 
1 Introduction ............................................................................................................................10 
1.1  Purpose ...................................................................................................................................... 10 
1.2  Scope ......................................................................................................................................... 10 
1.3  Intended Audience ..................................................................................................................... 11 
1.4  Normative References ............................................................................................................... 11 
1.5  Other References and Additional Reading ................................................................................ 11 
1.6  Background ................................................................................................................................ 12 
1.7  Changes in this Version ............................................................................................................. 12 
2 Overview of the ISBT 128 Standard .......................................................................................18 
2.1  Need for an International Standard ........................................................................................... 18 
2.2  Summary of the ISBT 128 Standard Technical Specification .................................................... 18 
2.3  ISBT 128 Data Structures .......................................................................................................... 19 
2.3.1  ISBT 128 Data Identifiers ...................................................................................................... 19 
2.3.2  Data Content ......................................................................................................................... 19 
2.4  ISBT 128-Specified Label .......................................................................................................... 25 
2.5  Concatenation ............................................................................................................................ 27 
2.6  Delivery Mechanisms ................................................................................................................. 28 
2.6.1  Linear Symbology: Code 128 ................................................................................................ 28 
2.6.2  Two Dimensional Symbologies ............................................................................................. 28 
2.6.3  Radio Frequency Identification Tags ..................................................................................... 29 
3 Use of ISBT 128 in the US .....................................................................................................30 
3.1  FDA Position .............................................................................................................................. 30 
3.2  AABB Position ........................................................................................................................... 30 
4 Data Structures ......................................................................................................................31 
4.1  Donation Identification Number [001] ........................................................................................ 31 
4.1.1  US Specification .................................................................................................................... 32 
4.2  ABO/Rh Blood Groups (002) ..................................................................................................... 34 
4.2.1  US Specification .................................................................................................................... 34 
4.2.2  Rh, Kell, and GP-Mur (Miltenberger III) Phenotypes............................................................. 36 
4.3  Product Code (003) ................................................................................................................... 40 
4.3.1  US Specification .................................................................................................................... 42 
4.4  Expiration Date and Time (005) ................................................................................................. 46 
4.4.1  US Specification .................................................................................................................... 46 
4.5  Collection Date (006) ................................................................................................................. 48 
4.5.1  US Specification .................................................................................................................... 48 
4.6  Collection Date and Time (007) ................................................................................................. 50 
4.6.1  US Specification .................................................................................................................... 50 
4.7  Special Testing: General (010) .................................................................................................. 51 
4.7.1  US Specification .................................................................................................................... 51 
4.8  Special Testing: Red Blood Cell Antigens (012)........................................................................ 51 
4.8.1  US Specification .................................................................................................................... 51 
4.9  Special Testing: Platelet HLA and Platelet-Specific Antigens (014).......................................... 51 
4.9.1  US Specification .................................................................................................................... 51 
5 Uniform Labeling Using ISBT 128 ..........................................................................................52 
5.1  Concepts .................................................................................................................................... 52 
5.1.1  Principles of Label Design ..................................................................................................... 52 
5.1.2  US Specification for Bar Code Text and Additional Text ...................................................... 53 
5.1.3  Label Design .......................................................................................................................... 53 
                                                                                                                                   
 
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  US Consensus Standard, Version 3.0.0      5 
5.1.4  Additional Labels ................................................................................................................... 61 
6 Printing ISBT 128 Product Description Labels ........................................................................63 
6.1  Rules for Printing ISBT 128 Product Description Label Text ..................................................... 63 
6.2  Proper Names of Products ........................................................................................................ 67 
6.3  Attribute Text ............................................................................................................................. 74 
6.4  Core Conditions Text ................................................................................................................. 81 
6.5  Coding and Labeling of Products for Further Manufacture ....................................................... 88 
6.6  Donation Type in Product Description Code ............................................................................. 91 
7 Illustrations of US Labels........................................................................................................94 
7.1  Introduction ................................................................................................................................ 94 
7.2  Container Manufacturers Base Label ....................................................................................... 94 
7.2.1  Container Manufacturer and Catalog Number ...................................................................... 95 
7.2.2  Base Label Illustrations ......................................................................................................... 96 
7.2.3  Final Primary Container Label Illustrations ........................................................................... 98 
7.3  Final Satellite Container Label Illustrations ............................................................................... 99 
7.4  Upper Right Quadrant .............................................................................................................. 101 
7.5  Lower Left Quadrant Labels .................................................................................................... 104 
7.6  Special Testing Labels ............................................................................................................. 109 
7.7  Autologous Label ..................................................................................................................... 111 
7.8  Labeling Specific Products ...................................................................................................... 112 
7.8.1  Pooled Blood Products ........................................................................................................ 112 
7.8.2  Reconstituted Red Blood Cells ............................................................................................ 115 
7.8.3  Divided Products ................................................................................................................. 118 
7.8.4  Frozen Red Blood Cells ...................................................................................................... 120 
7.8.5  Washed, Deglycerolized, or Rejuvenated Red Blood Cells ................................................ 121 
7.8.6  Granulocytes - Untested ...................................................................................................... 121 
7.8.7  Plasma Products ................................................................................................................. 122 
7.8.8  Thawed Plasma Products or Cryoprecipitated AHF............................................................ 122 
7.8.9  Apheresis Fresh Frozen Plasma ......................................................................................... 124 
7.8.10  Thawed Apheresis Fresh Frozen Plasma ....................................................................... 126 
7.8.11  Apheresis Red Blood Cells ............................................................................................. 127 
7.8.12  Pooled Platelets with Bacterial Monitoring or Bacterial Test .......................................... 127 
7.8.13  Apheresis Platelets ......................................................................................................... 128 
7.8.14  Recovered Plasma .......................................................................................................... 133 
7.8.15  Source Plasma ................................................................................................................ 135 
7.8.16  Source Leukocytes.......................................................................................................... 137 
7.8.17  Therapeutic Plasma for Manufacture .............................................................................. 139 
7.8.18  Additional Labeling by a Facility Modifying a Blood Product .......................................... 140 
7.9  Intended Recipient Information Label ...................................................................................... 143 
7.10  Additional Emergency Release Label ...................................................................................... 144 
7.11  Unexpected Antibodies ............................................................................................................ 144 
8 ICCBBA Databases..............................................................................................................1 45 
8.1  Facility Identification Number................................................................................................... 145 
8.2  Product Description Code ........................................................................................................ 145 
8.3  Special Testing: General ......................................................................................................... 146 
8.4  Manufacturer Identification Codes ........................................................................................... 146 
8.5  Structured Compound Messages ............................................................................................ 146 
9 Appendix Acceptable Abbreviations for Blood Label Text.....................................................1 47 
Glossary..................................................................................................................................1 48 
Index .......................................................................................................................................1 52 
   
 
 
                                                                                                                                   
 
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  US Consensus Standard, Version 3.0.0      6 
Tables 
 
Table 1  Changes and Corrections Between Version 2.0.0 and Version 3.0.0 ...........................13 
Table 2  ISBT 128 Data Structures ............................................................................................22 
Table 3  ABO/Rh Blood Groups Data Structure: Values of "gg" ................................................37 
Table 4  Values of gg for ABO/Rh Data Structure for Special Purpose Blood Groups ..........39 
Table 5  Proper Name (Based on Class and Modifier) ..............................................................67 
Table 6  Proper Name (Based on Class and Attribute) ..............................................................73 
Table 7  Attribute Text ...............................................................................................................74 
Table 8  Core Conditions Text ...................................................................................................81 
Table 9  Donation Type Text (Sixth Position in the Product Code Data Structure) ....................91 
Table 10  Source Donor Type Text .........................................................................................1 35 
Table 11  Licensure Status of Component ..............................................................................1 41 
Table 12  Appropriate Labeling of Licensed Products .............................................................1 41 
 
Figures 
 
Figure 1  Data Structure ............................................................................................................19 
Figure 2  Example of Data Content on a Label ..........................................................................21 
Figure 3  ISBT 128-Specified Label ...........................................................................................26 
Figure 4  Comparison of Code 128 and Data Matrix Symbols ...................................................29 
Figure 5  Donation Numbering ..................................................................................................32 
Figure 6  Product Code Structure ..............................................................................................42 
Figure 7  Donation Type Encoded in Product Code ..................................................................44 
Figure 8  Labeling of Divisions ..................................................................................................45 
Figure 9  Text When Expiration is Default Time of 23:59 ...........................................................47 
Figure 10  Expiration Date and Time .........................................................................................47 
Figure 11  Collection Date on Recovered Plasma Label ...........................................................48 
Figure 12  Collection Date on a Product for Transfusion ...........................................................48 
Figure 13  Final Label--Four Equally-Sized Labeling Quadrants: Placement of the Bar Codes .55 
Figure 14  Upper Left Quadrant--Standard ................................................................................56 
Figure 15  Upper Left Quadrant with Text Collection Date ........................................................57 
Figure 16  Upper Left Quadrant  Recovered Plasma ...............................................................57 
Figure 17  Lower Left Quadrant ................................................................................................58 
Figure 18  Upper Right Quadrant ..............................................................................................59 
Figure 19  Lower Right Quadrant for Product Leaving the Facility .............................................60 
Figure 20  Lower Right Quadrant for Incompletely Tested Allogeneic Units ..............................60 
Figure 21  Donor Untested Label for Autologous Units ..............................................................61 
Figure 22  Printing of Anticoagulant and Storage Temperature on Label...................................64 
Figure 23  Printing of Product Description Labels ......................................................................65 
Figure 24  Two Attribute Statements on a Single Line ...............................................................66 
Figure 25  Coding & Labeling of Products for Further Manufacture  Research and Injectable .89 
Figure 26  Coding & Labeling of Products for Further Manufacture  Noninjectable ..................90 
Figure 27  100 mm by 106 mm (4" x 4.25") Base label ..............................................................96 
Figure 28  Base Label for Small Container ................................................................................97 
Figure 29  Primary ContainerRed Blood Cells .......................................................................98 
Figure 30  Satellite Container--Platelets ....................................................................................99 
Figure 31  Satellite ContainerPLATELETSUS License Number in Upper Left Quadrant .. 100 
Figure 32  Rh Positive Label ...................................................................................................1 01 
                                                                                                                                   
 
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  US Consensus Standard, Version 3.0.0      7 
Figure 33  Rh Negative Label ..................................................................................................1 01 
Figure 34  Rh Not Specified Label...........................................................................................1 01 
Figure 35  Autologous Products for Upper Right Quadrant .....................................................1  02 
Figure 36  Directed, Designated and Dedicated Labels for Upper Right Quadrant .................. 102 
Figure 37  ABO/Rh for Emergency Release ............................................................................1 03 
Figure 38  Bombay and Para-Bombay Phenotypes ................................................................. 103 
Figure 39  Therapeutic Collection Upper Right Quadrant ........................................................1 03 
Figure 40  Whole Blood ...........................................................................................................1 04 
Figure 41  Whole Blood, Low Volume .....................................................................................1 04 
Figure 42  Red Blood Cells .....................................................................................................1 04 
Figure 43  Red Blood Cells with Additive.................................................................................1 04 
Figure 44  Divided RBCs .........................................................................................................1 04 
Figure 45  Irradiated RBCs......................................................................................................1 04 
Figure 46  Leukocytes Reduced RBCs ...................................................................................1 05 
Figure 47  Washed, Leukocytes Reduced RBCs .....................................................................1 05 
Figure 48  Irradiated, Leukocytes Reduced RBCs ................................................................... 105 
Figure 49  Deglycerolized RBCs .............................................................................................1 05 
Figure 50  Divided, Irradiated, Leukocytes Reduced Apheresis RBCs .................................... 105 
Figure 51  Red Blood Cells, Low Volume ................................................................................1 05 
Figure 52  Platelets .................................................................................................................1 06 
Figure 53  Pooled Platelets .....................................................................................................1 06 
Figure 54  Pooled Platelets -5d ...............................................................................................1 06 
Figure 55  Apheresis Platelets ................................................................................................1 06 
Figure 56  Low Yield Apheresis Platelets ................................................................................1 06 
Figure 57  Apheresis Platelets with PAS .................................................................................1 06 
Figure 58  Apheresis Plasma with 24 Hour Room Temperature Hold ...................................... 107 
Figure 59  Apheresis FFP .......................................................................................................1 07 
Figure 60  Plasma Frozen <24 Hours after Phlebotomy ..........................................................1 07 
Figure 61  Fresh Frozen Plasma .............................................................................................1 07 
Figure 62  Thawed Fresh Frozen Plasma ...............................................................................1 07 
Figure 63  Cryoprecipitated AHF .............................................................................................1 08 
Figure 64  Pooled Cryoprecipitated AHF .................................................................................1 08 
Figure 65  Thawed Pooled Cryoprecipitated AHF ...................................................................1 08 
Figure 66  Special Testing General and Red Cell Antigen Labels ........................................... 109 
Figure 67  Red Cell Antigen Label  Negative Antigens Only ..................................................1  09 
Figure 68  Full Label with Red Cell Phenotype ........................................................................1 10 
Figure 69  For Autologous Use Only Label ..............................................................................1 11 
Figure 70  Pooled Platelets, Mixed Anticoagulant ................................................................... 113 
Figure 71  Thawed Pooled Cryoprecipitated AHF, Rh Not Specified ....................................... 113 
Figure 72  Thawed Pooled Cryoprecipitated AHF, Group A, Rh Pooled .................................. 114 
Figure 73  Pooled Platelets .....................................................................................................1 14 
Figure 74  Reconstituted Red Cells, Pool Number Assigned ...................................................1  16 
Figure 75  Reconstituted Red Blood Cells, Original RBC DIN Retained .................................. 116 
Figure 76  Divided Product ......................................................................................................1 18 
Figure 77  Granulocytes ..........................................................................................................1 22 
Figure 78  Thawed Plasma with Manually Changed Expiration ...............................................1  23 
Figure 79  Thawed Plasma .....................................................................................................1 23 
Figure 80  Apheresis FFP with 1st Container Designation (Product Code E4689V00) ............ 124 
Figure 81  Apheresis FFP with 2nd Container Designation (Product Code E4693V00) ............ 124 
                                                                                                                                   
 
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  US Consensus Standard, Version 3.0.0      8 
Figure 82  Apheresis FFP with Division Code .........................................................................1 25 
Figure 83  Product with Container Number Further Divided ....................................................1  25 
Figure 84  Divided Product Further Divided .............................................................................1 26 
Figure 85  Apheresis Fresh Frozen Plasma, Open System .....................................................1  26 
Figure 86  Pooled Platelets with Bacterial Monitoring or Bacterial Test ................................... 127 
Figure 87  Container Code on Apheresis Platelets................................................................1  28 
Figure 88  Example Statement on Low Yield Collection ..........................................................1 28 
Figure 89  Example of Optional Platelet Yield Statement ........................................................1 29 
Figure 90  Divided Low Yield Product .....................................................................................1 31 
Figure 91  Divided Product (Yield 3 x 1011)............................................................................1 32 
Figure 92  Divided Product from Second Container ................................................................1  32 
Figure 93  Recovered Plasma ................................................................................................. 133 
Figure 94  Additional Recovered Plasma Label Examples Showing Lower Quadrants ............ 134 
Figure 95  Source Plasma .......................................................................................................1 36 
Figure 96  Source Leukocytes from Whole Blood ....................................................................1  37 
Figure 97  Source Leukocytes Collected by Apheresis ............................................................1 38 
Figure 98  Therapeutic Plasma for Manufacture into Noninjectable Products (Lower Quadrants)
 ...............................................................................................................................................1 39 
Figure 99  Product Modified by a Facility other than the Collection Facility ............................. 142 
Figure 100  Intended Recipient Information Label Examples...................................................1  43 
Figure 101  Emergency Release Test Results Tie Tag or Label ..............................................1  44 
Figure 102  Labeling for Unexpected Antibodies .....................................................................1  44 
Figure 103  Text Terminology in ISBT 128 Documents ...........................................................1 51 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      9 
 
Abbreviations and Acronyms 
   
 
2-D  Two dimensional 
ASCII  American Standard Code for Information Interchange 
ATAG  Americas Technical Advisory Group 
CCD  Charged Coupled Device 
CFR  Code of Federal Regulations 
DIN  Donation Identification Number 
FDA  Food and Drug Administration 
FIN  Facility Identification Number 
GS1  An international organization involved in setting 
standards for supply chain information 
IEC  International Electrotechnical Commission 
ISBT  International Society of Blood Transfusion 
ISO  International Organization for Standardization 
PLT  Platelets 
RBC  Red Blood Cells 
RFID  Radio Frequency Identification Tag 
US  United States 
WB  Whole Blood 
WBC  White Blood Cells 
 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      10 
1 Introduction 
1.1  Purpose 
 
The purpose of this document is to provide guidance on labeling requirements in the US 
for blood and blood components. 
 
1.2  Scope 
 
ISBT 128 is an international information standard for human blood, tissue, cellular therapy, 
organ, and milk products. A balance exists between what information on a product label 
must be strictly standardized in order to achieve the goals of an international standard and 
what must be left to the discretion of national authorities because of variations in language 
and regulatory requirements. Broadly, this can be divided as follows: 
 
Internationally defined: The definitions of data structures and the placement of bar 
codes, as well as the corresponding data content text that appears immediately beneath a 
bar code, are strictly standardized. These label elements must appear exactly as specified 
in the ISBT 128 Standard Technical Specification.  
 
Nationally defined: Bar code text (the interpretation of the information in the bar code) 
and additional text are generally left to national authorities to define. Additionally, the use 
of some data structures, such as the collection date on the label, is nationally defined. 
These decisions are codified by national working groups established for this purpose 
unless superseded by regulatory authority. In the US this working group is the Americas 
Technical Advisory Group (ATAG) of ICCBBA.  
 
This document, The United States Industry Consensus Standard for the Uniform Labeling 
of Blood and Blood Components Using ISBT 128, provides specific instructions for the US 
where there is flexibility in the ISBT 128 Standard Technical Specification.  
 
What it contains: 
This document provides specific information for the text that must appear on US 
labels and provides many example labels meeting the requirements in the US. 
While it is not possible to provide an example of every type of product label, this 
document should provide enough examples to enable users to develop their own 
label. 
 
Text shown in example labels and on various tables in this document represents 
ICCBBAs recommendations. Other variations of the wording, capitalization, or 
punctuation may also be acceptable. Users are advised to consult the FDA to 
determine if a proposed variation is acceptable. 
 
What it does not contain: 
It does not provide detailed guidance for final labels on smaller pediatric containers. 
Smaller labels should follow the principles outlined for larger labels, but will have to 
be designed with the smaller size taken into consideration.  
 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      11 
It does not cover details about the required quality of bar codes nor their precise 
placement. This information is contained in the ISBT 128 Standard Labeling of 
Blood Components. 
 
It does not provide detailed information about product coding. Specific information 
about product coding may be found in a document called Use of Product Code 
Data Structure [003]  Blood. Specific information about the terminology used in 
product coding is found in a document called Standard Terminology for Blood, 
Cellular Therapy, and Tissue Product Descriptions.  
 
1.3  Intended Audience 
 
The intended audience of this document is transfusion medicine facility staff 
(management, information technology, quality, validation, and laboratory), auditors, 
software developers, and vendors of equipment and consumables. It is intended to help 
these people understand labeling requirements and to standardize to the extent possible 
labeling of blood and blood components in the US. 
 
1.4  Normative References 
 
ICCBBA 
ISBT 128 Standard Technical Specification (ST-001) 
ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product 
Descriptions (ST-002) 
ISBT 128 Standard Labeling of Blood Components (ST-005) 
 
AABB  
Standards for Blood Banks and Transfusion Services 
 
FDA 
21 CFR 606.121 
21 CFR 610.40 
21 CFR 610.53  
21 CFR 610.60  
21 CFR 640.3 
21 CFR 640.70 
21 CFR 640.3(d)  
21 CFR 640.120 
Federal Register/Vol 48, No. 64/Friday, April 1, 1983/Notices 
 
1.5  Other References and Additional Reading 
 
ICCBBA Website (www.iccbba.org) 
AABB Website (www.aabb.org) 
FDA Website (http://www.fda.gov/BiologicsBloodVaccines/default.htm) 
 
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics 
(FDA, November 2008) 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      12 
 
Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated 
Methods (December 2007) 
 
Implementation Guide: Use of Product Code Data Structure [003]  Blood (IG-021) 
Implementation Guide: Use of the Manufacturers Data File (IG-015) 
Technical Bulletin 9: Blood Bag Identification Using ISBT 128 and GS1 (IG-012) 
Technical Bulletin 10: Valid and Invalid Bar Codes for Use in ISBT 128 Validations 
(IG-013) 
Technical Note 1: Case Conversion (IG-016) 
Technical Note 2: Length of the Product Code Bar Code and Concatenation (IG-017) 
Technical Note 4: Manufacturer Catalog Number and Lot Number (IG-019) 
 
1.6  Background 
 
A specification for ISBT 128 labeling of blood products was developed by the International 
Society of Blood Transfusion Working Party on Automation and Data Processing 
(WPADP) [now called the Working Party on Information Technology] and published by 
ICCBBA in 1995. Around the world, implementation in blood establishments began soon 
after the standard was issued, with a steady increase in adoption since that time. The 
model originally developed by the WPADP has demonstrated its suitability by 
accommodating local and regional changes without requiring substantial structural 
change. The standard has since been expanded for use with cellular therapy and tissue 
products. 
 
In the US, blood centers have been converting to ISBT 128 over the past decade, led by 
the Department of Defense and the Community Blood Center of Greater Kansas City. In 
2008, AABB required the use of ISBT 128 by its accredited facilities. 
 
1.7  Changes in this Version 
 
Version 3.0.0 of this document is considerably reorganized and expanded from Version 
2.0.0. Many more examples of labels and text are included to help US users standardize 
labels while meeting the requirements of the FDA, AABB, and the ISBT 128 Standard. 
While Table 1 notes specific changes and corrections, the document must be read in its 
entirety. 
 
ISBT 128 is a living system. This document, and other documents important to ISBT 128, 
will be subject to a continual revision process. Care is taken to ensure any changes are 
backward compatible. Users should be sure that they have the most recent version of any 
document; a listing of current versions is maintained on the ICCBBA Website.  
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      13 
Table 1  Changes and Corrections Between Version 2.0.0 and Version 3.0.0 
 
  Section in  Section in  Change  Rationale 
Version  Version 
2.0.0  3.0.0 
1    Throughout  Version 3.0.0 includes  Response to questions 
changes in organization as  posed to the ICCBBA office 
well as many more examples  since the publication of 
and explanations.  version 2 of this document. 
2    Throughout  On example labels  To be in compliance with 
throughout the document,  CFR. 
capitalization has changed on   
three warning phrases. It is   
now:    
 Properly identify   
intended recipient.   
 See circular of   
information for   
indications,   
contraindications,   
cautions, and   
methods of infusion.   
 Rx only 
3    Throughout  On label examples  To reduce the amount of 
throughout the document, the  space needed to print this 
option has been provided to  information. 
abbreviate two statements for 
test results: 
 
Anti-CMV Neg. 
Hgb S Neg. 
4    2.6.2  Indicated 2-D bar codes could  While it is expected that 
be used on blood labels, but  facilities will move toward the 
that they cannot be the sole  use of 2-D bar codes in the 
means of communicating  future, time must be allowed 
electronic information for the  for facilities to obtain 
DIN, product code, ABO/Rh,  appropriate scanners to be 
and expiration date.  purchased and software to 
be updated to read this 
critical information. 
5  Throughout  Throughout  The term eye-readable text  Consistent with other ISBT 
was changed to data content  128 documents. 
text  Eye-readable text had a 
common definition different 
from that used within the 
ISBT 128 standard and this 
could be confusing. 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      14 
6  1  3.1  A variance from the FDA is no  Change in regulations 
longer required to use ISBT 
128 proper names.  
7  3.5.2.1.2  4.1.1.2  The Donation Identification  All characters of the DIN are 
Number must be printed such  equally important. Printing 
that all characters are of the  some characters with a 
same font, point size, and  different prominence may 
color.  give the incorrect impression 
that only the emphasized 
numbers need to be 
recorded. 
8  3.5.2.1.3  4.1.1.3  Flag characters in the DIN will  The direction of the rotation 
be rotated 90 degrees  was not stated in Version 
clockwise.  2.0.0. This is now 
standardized. 
9  Table 3  Table 3  Added coding options for  Requested by international 
para-Bombay phenotypes  users 
   
Moved pooled product blood  More logical 
groups from Special  placement. Note: The codes 
Messages table to ABO/Rh  for these pooled blood 
table.  groups have not changed; 
only the table in which they 
appear has changed.  
 
10    4.3.1.1  Added national Product  Allow the US to create 
Description Codes B7000  national Product Description 
through B9999.  Codes if needed. 
11  3.5.5.3.1    Previous version stated  Version 2.0.0 incorrectly 
Platelets Pheresis  7d is the  stated the proper name of 
Proper Name   this product is Platelets 
Pheresis - 7d. While 
Apheresis Platelets  7d was 
the proper name, this was 
deleted in Version 3 because 
this product is no longer 
available in the US. 
12  3.5.5.3.3  4.3.1.4  Autologous donations must  Version 2.0.0 incorrectly 
be encoded with a 1 or an  stated that V may be used if 
X.  one of the optional codes is 
not used. V may only be 
used for allogeneic 
donations.  
13  3.5.5.3.3   4.3.1.4  Added the code 0 (zero) for  Error correction. 0 may be 
when the donation type is not  used in the US for recovered 
specified.   plasma, source plasma, and 
source leukocytes (but for no 
other blood products).  
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      15 
14  3.5.5.3.3  4.3.1.4  Added a note that while the  This was a decision of the 
use of D in the Product  Americas Technical Advisory 
Code is optional in Version  Group (ATAG) to improve 
3.0.0, it will become  the likelihood that a directed 
mandatory in the next  unit will be associated with 
published version of this  the appropriate recipient. 
document. 
15  4.1.4.1    Deleted the requirement to  Decision of ATAG to allow 
right justify the Donation  printing the Donation 
Identification Number.  Identification Number in a 
larger type size. 
16  4.1.4.1,  5.1.3.1,  Caution statement must read,  Version 2.0.0 incorrectly 
Figure 4  Figure 14  This product may transmit  printed this statement 
infectious agents.  without the words This 
product. 
17  4.1.4.1  5.1.3.1  Right justified collection date  To be consistent with 
Figure 5  Figure 16  bar code.  international design. 
18  4.1.4.4  5.1.3.4  The name of the facility that  The inclusion of the name of 
modified or further processed  the modifying facility is 
a product must be on the label  optional if the product does 
ONLY if the product leaves  not leave the facility. 
the facility. 
19    5.1.3.4  The phrases DONOR  This wording is required by 
TESTED WITHIN THE LAST  the FDA if the donor unit is 
30 DAYS or DONOR  not tested. This was not 
UNTESTED (autologous  detailed in version 2.0.0. 
units) appears in the lower 
right quadrant, when 
appropriate. 
20    5.1.3.4  The phrase SEE TIE TAG  Ensure the information 
FOR TEST RESULT  regarding incomplete test 
INFORMATION (allogeneic  status is clearly indicated to 
units) appears in the lower  the user. 
right quadrant, when 
appropriate. 
21  5.3.1,  7.2.2,  Examples were changed to  Non-ISBT 128 information on 
Figures  Figure 27  show only the minimum  base labels has not been 
10-13  and  required ISBT 128  standardized.  
Figure 28   information on the base label. 
22  5.4, Figure  7.2.3,  Caution statement must read,  Version 2.0.0 incorrectly 
13;  Figure 29;  This product may transmit  printed this statement 
5.4, Figures  7.3,  infectious agents.  without the words This 
14-17   Figure 30  product. 
 
23  5.6, Figure  7.5, Figure  On the example label for  In Version 2.0.0, POOLED 
23  64  POOLED  was incorrectly printed as a 
CRYOPRECIPITATED AHF,  Modifier. 
POOLED is printed as part of 
the Class name. 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      16 
24  5.6, Figure  7.8.17,  The word Therapeutic  Consistency. 
25  Figure 98  should appear beneath the 
bar code justified to the right 
edge of the bar code. Test 
results should appear in the 
lower right quadrant. 
25  7    Deleted the chapter on other  This information is now found 
documents to consult.  on the ICCBBA Website 
where it can be updated 
more frequently and in 
Sections 1.4 and 1.5.  
26  Appendix B  6.2, Table  Platelet Rich is indicated to be  Version 2.0.0 indicated 
5  part of the Class for Platelet  Platelet Rich was a Modifier. 
Rich Plasma.    Platelet Rich is part of the 
Class, not a Modifier. 
27  Appendix B  6.2, Table  For Leukocytes (whole blood  FDA requirement. 
6 and  derived), the following 
7.8.16  sentence appears, If the 
product is to be used for 
further manufacturing, it will 
be labeled, SOURCE 
LEUKOCYTES. 
28  Appendix C  6.3, Table  The words OPEN SYSTEM  Unless otherwise stated, the 
7  will be printed on the label if  default value of an Attribute 
the product is made in an  group is assumed. For the 
open system.   System Integrity Attribute 
group, the default is closed.  
Therefore, it is assumed the 
product was made in a 
closed system unless 
otherwise stated. This 
change to US requirements 
is required to allow facilities 
to determine appropriate 
dating on thawed products. 
For example, if an apheresis 
FFP was made in a closed 
system, it may be converted 
to Thawed Plasma and given 
a 5-day outdate. If it is made 
in an open system, the dating 
on the thawed product may 
not be extended to 5 days.  
29  Appendix C  6.3, Table  Added Donor Exposure group  New Attribute group 
7 
30    6.4, Table  Included instructions for  Platelet additive solutions 
8  labeling platelets with platelet  may be used in the US. 
additive solutions. 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      17 
31  Appendix D  6.6, Table  Added the code 0 (zero).  This code may be used in the 
9  US for Recovered Plasma 
and Source Plasma, as well 
as Source Leukocytes. 
32  Appendix D  5.1.3.3  For donation types with  This had been inconsistently 
Biohazard, the word  presented in Version 2.0.0.  
Biohazard should appear 
before the phrases For 
Designated Recipient Only 
or For Autologous Use Only. 
33     7.8.9  Added that in the US,  Decision of the ATAG to 
apheresis plasma divided into  increase flexibility and to 
multiple ADULT doses may  allow for plasma apheresis 
be labeled either with different  collection kits that have 
Product Description Codes  multiple bags for collection 
(indicating different  and storage of plasma. 
containers) or as division 
codes (7th and 8th characters 
of the Product Code). 
34    8.1  Added that the facility  Clarity. 
name/location that appears in 
the ICCBBA Facility 
Identification Number 
database should be the legal 
name and location of the 
facility. For FDA-licensed 
facilities, it should be the 
name and location on the 
FDA license. For 
FDA-registered (but not 
licensed) facilities, it should 
be the name and location as it 
appears on the FDA 
registration. 
 
Please note that this table represents only major changes and 
corrections to Version 2.0.0. The document must be read in its 
entirety because of the expansion of many sections. 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      18 
2 Overview of the ISBT 128 
Standard 
 
2.1  Need for an International Standard  
 
A great deal of important information is presented on a blood product label. This 
information varies from country to country according to regulations, language differences, 
and local transfusion practice. In todays world of multinational disaster relief programs 
and multinational military operations, blood collected and processed in one country may 
be used in another. It is essential that critical information such as ABO and Rh, expiration 
date, and product description be clearly understood by medical personnel transfusing the 
blood product. Given the concerns about safety and traceability, it is also important that 
these data be easily captured by a computer system and that each product is uniquely 
identified on a global basis. These goals are easier to achieve if there is standardization in 
blood product labeling. 
 
However, ISBT 128 is more than a labeling system; it is an information standard. This 
means it is designed to transfer information about blood and other products of human 
origin electronically and is independent of the mechanism of transfer. ISBT 128 supports 
information transfer by a variety of mechanisms such as linear bar codes, two-dimensional 
(2-D) symbols, radio frequency identification (RFID) tags, and electronic messaging.  
 
2.2  Summary of the ISBT 128 Standard Technical 
Specification 
 
The ISBT 128 Standard Technical Specification defines the rules for the use of ISBT 128 
internationally. It: 
 
  defines the data identifiers used in the transfusion and transplantation environments; 
 
  defines the data structures that carry information, i.e., how a particular bar code will be 
recognized by a reader, how many characters are present, and whether the characters 
are letters, numbers, or both; 
 
  includes tables that define how bar codes should be translated; 
 
  describes the layout for a blood product label, including the precise placement of bar 
codes; 
 
  defines technical details for the Code 128 and Data Matrix bar codes, such as the 
width of the narrowest bars and print quality requirements; and 
 
  describes the variation made in Code 128 to support specialized concatenation. 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      19 
 
 
 
2.3  ISBT 128 Data Structures  
 
Data structures define the way in which information is presented in ISBT 128. There are 
many data structures, only some of which are used on blood labels. Examples of data 
structures which encode information that does not appear on the label include Staff 
Member Identification Number and Patient Identification Number. Table 2, page 22, is a 
list of the ISBT 128 defined data structures that was complete at the time this document 
was published. Consult the ISBT 128 Standard Technical Specification for the most recent 
list. 
 
Each data structure consists of data identifier characters and data content (see Figure 1) 
and is very precisely defined in terms of its length and permissible characters (see Table 2, 
page 22). 
Figure 1  Data Structure 
   
=< E1234V00 
 
  Data  Data Content 
Identifier 
 
2.3.1  ISBT 128 Data Identifiers 
 
Each data structure begins with two characters which are called the data identifier. 
Data identifiers define the type of information the bar code contains.  
 
The first character will always be = or &. By international agreement these 
characters are reserved for ISBT 128 data structures.  
 
The second character distinguishes the type of ISBT 128 information to be 
conveyed. For example, the two characters =% at the beginning of a data 
structure indicate that the bar code carries information about the ABO/Rh Blood 
Groups whereas =< means the bar code carries information about the Product 
Code. Table 2 indicates the data identifier for each ISBT 128 data structure. 
Consult the ISBT 128 Standard Technical Specification for the most recent list. 
2.3.2  Data Content 
 
Data content is the information to be conveyed. For example, the information to be 
communicated is that the product is A, Rh Positive. This information is encoded to 
allow it to be efficiently transferred electronically so that A, Rh Positive becomes 62. 
Internationally agreed upon reference tables are used to encode and decode 
information. See Table 3, page 37, for an example of such a reference table. Some 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      20 
of these reference tables are found in the ISBT 128 Standard Technical 
Specification; others are found on the ICCBBA Website. 
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      21 
The data content appears in an eye-readable form beneath a linear bar code on an 
ISBT 128 label. 
 
Figure 2  Example of Data Content on a Label 
 
 
 
 
Data content 
 
 
 
 
 
 
 
 
 
 
Data characters are the individual ASCII characters that make up the data content.
                                                                                                                                   
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0      22 
Table 2  ISBT 128 Data Structures 
 
 
First 
Character of 
the Data  Second Character of 
Identifier  the Data Identifier 
 
  ASCII     
  Value    ASCII Value  Data Content 
Ref  Data Structure Name 
     
001   =   61  AN; PZ; 19  ppppyynnnnnnff 
Donation Identification Number 
           
 
002   =   61  %  37  ggre 
Blood Groups [ABO and RhD] 
             
003  Product Code   =   61  <  60  ooootds 
           
 
004   =   61  >  62  cyyjjj 
Expiration Date 
             
005  Expiration Date and Time  &  38  >  62  cyyjjjhhmm 
           
 
006   =   61   *   42  cyyjjj 
Collection Date 
             
007  Collection Date and Time  &  38   *   42  cyyjjjhhmm 
             
008  Production Date   =   61  }  125  cyyjjj 
             
009  Production Date and Time  &  38  }  125  cyyjjjhhmm 
             
010  Special Testing: General  &  38  (  40  zzzzz 
 
  Special Testing: Red Blood Cell           
011  Antigens [Retired]   =   61  {  123  aaaaaaaaaaaaaaaaii 
  Special Testing: Red Blood Cell           
012  Antigens -- General   =   61  \  92  aaaaaaaaaaaaaaaaii 
 
 
 2013 ICCBBA   All rights reserved    www.iccbba.org 
  US Consensus Standard, Version 3.0.0      23 
First 
Character of 
the Data  Second Character of 
Identifier  the Data Identifier 
 
  ASCII     
  Value    ASCII Value  Data Content 
Ref  Data Structure Name 
 
  Special Testing: Red Blood Cell           
013  Antigens -- Finnish  &  38  \  92  aaaaaaaaaaaaaaaaii 
 
  Special Testing: Platelet HLA and           
014  &  38  {  123  AAAABBBBCCCCCCCCDE 
Platelet-Specific Antigens 
 
  Special Testing: HLA-A and -B           
015  Alleles [Retired]   =   61  [  91  EEEEFFFFGGGGHHHHLM 
 
  Special Testing: HLA-DRB1 Alleles           
016  [Retired]   =   61  "  34  IIIIJJJJMMMMMMMMMM 
 
  Container Manufacturer and Catalog           
017  Number   =   61  )  41  bqqwwwwwww 
             
018  Container Lot Number  &  38  )  41  xxxxxxxxxx 
             
019  Donor Identification Number   =   61  ;  59  ppppvvvvvvvvvvvvvvvv 
             
020  Staff Member Identification Number   =   61  '  39  ppppuuuuuu 
 
  Manufacturer and Catalog Number:           
021  Items Other Than Containers   =   61  -  45  NNOOOOOOOO 
 
  Lot Number: Items Other Than           
022  Containers  &  38  -  45  PPPPPPPPPP 
Compound Message   =  61  +  43  aabbb 
023 
Patient Date of Birth  =  61  #  35  aayyyymmdd 
024 
Patient Identification Number  &  38  #  35  aallxx...xx 
025 
Expiration Month and Year  =  61  ]  93  yyyymm 
026 
Infectious Markers  &  38    34  nnnnnnnnnnnnnnnnnn 
027 
 
 
 2013 ICCBBA   All rights reserved    www.iccbba.org 
  US Consensus Standard, Version 3.0.0      24 
First 
Character of 
the Data  Second Character of 
Identifier  the Data Identifier 
 
  ASCII     
  Value    ASCII Value  Data Content 
Ref  Data Structure Name 
  36 
 
Product Consignment  =  61  $  ppppyynnnnnccdd 
028 
36  nnaabbbbcccccdee... 
Dimensions  &  38  $  aabbbbcccccdee 
029 
 
Red Cell Antigens with Test History  &  38  %  37  nnnpppppprrss...pppppprrss 
030 
Data structures not defined by  &  38  a-z  These data identifiers may be 
ICCBBA  assigned by a facility or a regional, 
national, or super national authority,  
 
Reserved Data Identifiers for a 
Nationally-Specified Donor 
Identification Number  &  38  ;  59  Defined nationally 
 
Confidential Unit Exclusion Status 
Data Structure  &  38  !  33  Defined nationally 
 
 
 
 2013 ICCBBA   All rights reserved    www.iccbba.org 
  US Consensus Standard, Version 3.0.0    25 
2.4  ISBT 128-Specified Label 
 
The ISBT 128 blood product label is divided into four quadrants of equal size, 50 mm (2") 
wide by 50 mm (2") long. Regardless of site of collection worldwide, the bar codes should 
be placed in the same relative positions. The ISBT 128 Standard Technical Specification 
defines the placement of the following bar codes (see Figure 3, page 26). 
 
Base Label: 
 
 Container Manufacturer Identity and Catalog Number 
 
 Container Lot Number 
 
Final Label: 
 
 Donation Identification Number 
 
 ABO/Rh Blood Groups [Kell and Rh phenotypes] [Type of Donation or Collection] 
 
 Product Code [Type of Donation or Collection] 
 
 Expiration Date and Time 
 
 Collection Date or Collection Date and Time 
 
 Special Testing 
 
Not all bar codes must appear on all US products. Requirements are defined in sections 
for US Specifications for each data structure in Chapter 4. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    26 
 
Figure 3  ISBT 128-Specified Label 
                                     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A  Base label      
B  Final container label 
 
Key:  1  Container Manufacturer Identity and Catalog Number 
  2  Container Lot Number 
  3  Donation Identification Number   
  4  ABO/Rh Blood Groups 
  5  Product Code 
  6  Expiration Date and Time 
  7    Collection Date (and Time) 
  8  Special Testing 
 
     
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    27 
The Container Manufacturer Identity and Catalog Number bar code and the Container Lot 
Number bar code are part of the container manufacturers base label (A on Figure 3). Both 
of these bar codes will be covered by final labeling, although the data content text below 
the bar codes should remain visible.  
 
Bar codes 3 through 8 are part of final labeling (B on Figure 3). Bar code 6 is the Expiration 
Date and Time; this information is not required to be bar coded in the US. Bar code 7 is the 
Collection Date or Collection Date and Time, it is only used on certain products (e.g., 
Recovered Plasma), and this information is not required to be bar coded in the US. Bar 
code 8 (Special Testing) is optional information and may or may not appear on the final 
label. 
 
With the exception of the Donation Identification Number, for which the eye-readable 
information is presented in a specialized way, the data characters in the bar code are 
printed immediately below each linear bar code symbol. This text is called data content 
text (to understand text terminology used in this document, see Figure 103, page 151) and 
is standardized globally.  
 
The eye-readable representation of the interpreted bar coded information, called bar code 
text in this document, and any other text on the label, called additional text in this 
document (again, see Figure 103, page 151), are defined by each country to meet its own 
requirements. This document defines the bar code text and additional text for the US. 
 
2.5  Concatenation 
 
Concatenation is the term used to describe the reading of two (or more) bar codes as if 
they were a single bar code. Details are given in the ISBT 128 Standard Technical 
Specification. There is no US requirement that concatenation be used, but it does provide 
improved process control. 
 
The value of concatenation is the ability to check that two bar codes are attached to a 
single unit. This is accomplished by requiring that the second bar code be read within a 
time period too short to permit reading a bar code not on the same unit. In designing ISBT 
128, two pairs of bar codes are placed in horizontal alignment for ease of concatenation. 
The first pair, the Donation Identification Number and the ABO/Rh Blood Groups bar 
codes, ensures that the ABO/Rh label applied is correct according to the data in the host 
computer for the particular unit. The second pair, the Product Code and the Expiration 
Date and Time bar codes, should also be consistent since the Product Code can change 
during further manufacturing requiring a corresponding change in the Expiration Date and 
Time.  
 
The ISBT 128 label was designed specifically so that these two pairs of bar codes could 
be concatenated. However, in applications other than the standard blood label, different 
pairs of bar codes may be concatenated if desired.  
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    28 
2.6  Delivery Mechanisms 
 
ISBT 128 data structures are symbology-independent allowing them to be used with new 
bar code symbologies or other data capture technologies. 
2.6.1  Linear Symbology: Code 128 
 
The linear symbology selected for ISBT 128 bar code labeling is Code 128. Code 
128 was chosen for several reasons. First, it is a secure symbology. In addition to 
each Code 128 character being self-checking (three different ways), there is a 
built-in check digit. Misreads due to a single substitution error are extremely rare; 
scanning errors (when they occur) generally produce no-reads rather than 
misreads. Security of data capture is thereby increased dramatically. 
 
Next, Code 128 has three subsets, A, B, and C. Alphabetic characters are 
available in subsets A and B and allow more flexibility in coding highly variable 
information. The double-density coding of numeric characters supported by subset 
C allows more information to be encoded in a given space. This is important 
because of the limited space on blood container and sample tube labels. 
 
Finally, Code 128 is used extensively by many industries making it easy to find 
scanners capable of reading it. 
2.6.2  Two Dimensional Symbologies 
 
2-D symbologies are used where there is a great deal of information to convey and 
little space on the label. See Figure 4. All of the information encoded into the five 
Code 128 linear bar codes on the left side of this figure is encoded into the single 
Data Matrix symbol on the right. 
 
There are a variety of 2-D symbologies available. If an ISBT 128 2-D symbol is 
used on a blood, cellular therapy, or tissue product label, then Data Matrix must be 
used. For technical details about the use of Data Matrix, see the ISBT 128 
Standard Technical Specification, Implementation Guide: Use of Data Matrix 
Symbols with ISBT 128, and ISO/IEC 16022:2006(E): Information 
TechnologyInternational Symbology specificationData Matrix. Currently there 
are no specific recommendations for the use of Data Matrix symbols on blood 
labels in the United States. The use of 2-D symbols on cellular therapy labels is 
described in the United States Consensus Standard for the Uniform Labeling of 
Cellular Therapy Products Using ISBT 128.  
 
Reading the 2-D symbols requires an imaging scanner. Imaging scanners are able 
to read both 2-D and linear bar codes such as Code 128. Because 2-D symbols 
may be used in the future on cellular therapy products, derivatives, patient 
wristbands, and even blood labels, facilities may wish to consider purchasing 
imaging scanners when their current scanners are replaced. 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    29 
In the US, a 2-D bar code may not be the sole means of communicating electronic 
information for the DIN, product code, ABO/Rh, or expiration date on blood 
products at this time.  
 
Figure 4  Comparison of Code 128 and Data Matrix Symbols 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.6.3  Radio Frequency Identification Tags 
 
The use of Radio Frequency Identification (RFID) tags in transfusion medicine is 
being explored at the current time. If RFID technology proves suitable for 
transfusion medicine, ISBT 128 data structures can be used to transfer information 
through this technology. 
 
For further information on the use of RFID technology, see: Knels R, Davis R, 
Ashford P, et al: Guidelines for the use of RFID technology in transfusion medicine. 
Vox Sang 2010; 98(s2):1-24. 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    30 
 
3 Use of ISBT 128 in the US 
 
This US Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components 
Using ISBT 128 blends the requirements of the AABB and FDA with the ISBT 128 international 
model. Individuals from FDA and AABB participate in the Americas Technical Advisory Group 
(ATAG) of ICCBBA to ensure this document continues to reflect the requirements of FDA and 
AABB. 
 
3.1  FDA Position 
 
FDA first recognized the ISBT 128 Standard in an FDA guidance published in 2000. In 
2006, FDA published the updated US Industry Consensus Standard for the Uniform 
Labeling of Blood and Blood Components Using ISBT 128, Version 2.0.0, as a guidance 
document (this document was written at the end of 2005). 
 
ISBT 128 was developed as an international standard. Therefore the ISBT 128 
component name (with any appropriate Modifiers and Attributes) does not always match 
the proper names of components in the Code of Federal Regulations (CFR). A specific 
instance of this is Cryoprecipitated AHF. In the international database, this product is 
called Cryoprecipitate. Other examples of US proper names that are different from ISBT 
128 class names appear in Section 6.2.  
 
FDA licensed establishments should submit copies of their ISBT 128 labels for licensed 
products to the FDA for approval.  
 
FDA does not require ISBT 128. However, it does require that certain information on the 
label [unique facility identifier, lot number relating to the donor (called Donation 
Identification Number in this document), ABO/Rh of the donor, and Product Code] be 
machine readable. In publishing the US Industry Consensus Standard for the Uniform 
Labeling of Blood and Blood Components Using ISBT 128 as a guidance document, FDA 
has recognized that ISBT 128 labels meet these requirements. 
 
The Code of Federal Regulations takes precedence over this and other ISBT 128 
documents for blood product labeling in the US. 
 
The inclusion of example labels in this consensus document for any given product does 
not necessarily mean that the product is an FDA-licensable product. 
 
3.2  AABB Position 
 
The AABB Standards require that blood be labeled using ISBT 128 in its accredited 
facilities (both within and outside the US). 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    31 
4 Data Structures 
 
The ISBT 128 Standard Technical Specification describes all ISBT 128 data structures. The 
following sections discuss those data structures with unique US specifications. 
 
4.1  Donation Identification Number [001] 
 
This data structure provides for the unique identification of any donation or product pool 
worldwide for a one hundred year period.  
 
The Donation Identification Number (DIN) has 13 data characters: 
 
ppppyynnnnnn 
where:   
pppp  designates the collection or pooling facility; 
yy  designates the year in which the donation or collection was 
made; 
nnnnnn  is a serial number associated with the donation, collection, or 
pooled product. 
 
Other data characters incorporated into this bar code are flag characters. These may be 
used to assist in process control (such as identifying materials used in the collection 
process  container 1, container 2, tube 1, tube 2, etc.  permitting verification that the 
bar code has been scanned from the expected location   from container 1, etc.) or to 
support additional checks for accurate data transmission. The specific meaning 
associated with flags is defined in the ISBT 128 Standard Technical Specification. Flag 
characters are the last two characters of the DIN data structure. However, they are not 
part of the DIN itself. Flag characters are to be used in process control; it is not intended 
that they be recorded as part of the DIN in facility documents. 
 
The flag characters will be read by the bar code scanner and interpreted by the host 
computer software in collecting and/or processing facilities. Outside of the collection 
and/or processing facility, the flag characters may not be meaningful.  
 
An additional check character (not the same check character integral to every Code 128 
bar code) calculated on the entire 13 data character DIN (ppppyynnnnnn) will be printed, 
enclosed in a box, to the right of the DIN. The ISO modulo 37-2 method is used to compute 
this check character. This check character can be used to ensure the accuracy of 
keyboard data entry when appropriately supported by computer software.  
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    32 
 
Figure 5  Donation Numbering 
 
 
4.1.1  US Specification 
 
4.1.1.1  Application  
 
The DIN must be machine and eye-readable. 
 
Usually, the DIN is the first label applied to collection containers intended to 
contain blood products. It is applied before whole blood or apheresis 
products are collected.  
 
For pooled products, a unique identification number must be assigned. 
This number should be in the same format as the DIN and reflect the 
Facility Identification Number of the pooling facility. 
 
4.1.1.2  Printing the DIN 
 
The eye-readable DIN, flag and check characters will appear as follows: 
 
The DIN is divided into three parts (Facility Identification Number, year, and 
serial number) in its eye-readable form for ease in reading. This should 
facilitate checking and recording the DIN into records when the bar code is 
not scanned.  
 
No portion of the 13-character DIN shall be emphasized. That is, the entire 
number must appear in the same size, font, and color.  
 
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  US Consensus Standard, Version 3.0.0    33 
 
4.1.1.3  Flag Characters 
 
Flag characters may be used as detailed in the ISBT 128 Standard 
Technical Specification. The default or null value, 00, should always be 
present as part of the DIN bar code when other flags are not used.  
 
As shown in Figure 5, page 32, flag characters are printed in a way that 
identifies their special role, either rotated 90 degrees clockwise (i.e., 
printed vertically rather than horizontally) or in pictorial or iconized 
format (e.g., a picture of a test tube). 
 
4.1.1.4   Keyboard Entry Check    
 
Although keyboard entry of the DIN into a computer system is strongly 
discouraged, there will be times when it is necessary. Computer system 
software should be designed to recognize keyboard entry of the DIN and to 
require verification of data entry by the additional check character 
described above. 
 
Keyboard check characters should be printed within a box as shown in 
Figure 5, page 32. 
 
4.1.1.5  Avoiding Label Waste  
 
Preprinted DINs may be used over a fourteen month period to cut down on 
waste. For example, labels bearing the year 14 may be used from 
December 1, 2013 through January 31, 2015. The collection facility must 
have an accurate record of the actual date of collection. The rationale 
behind allowing the 14-month tolerance in the collection year appearing in 
the DIN is that this year notation is present only to ensure uniqueness of 
the DIN every 100 years. It does not in any way replace the expiration date 
(or collection date, as appropriate) on the label. 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    34 
4.2  ABO/Rh Blood Groups (002) 
 
This data structure has four (4) data characters: 
 
ggre 
where: 
 
gg  designates the ABO and Rh blood groups and certain other 
information (see below); 
r  specifies Rh and Kell or GP-Mur (Miltenberger III) phenotype              
information; 
e  is reserved for future use. 
 
Special messages, e.g., FOR LABORATORY RESEARCH USE ONLY, and other 
information may be encoded instead of ABO and Rh blood group information if 
appropriate (see Table 4, page 39).  
4.2.1  US Specification  
 
The ABO/Rh must be machine and eye-readable. 
 
Data characters r and e are not used in the US and should always be shown as 
00. 
 
The type of donation or collection should be specified in this bar code in 
accordance with Table 3, page 37. 
 
Text should be printed:  
 
  ABO text  Rh text  Example 
Rh Positive  Solid black  Black on white  Figure 32, Page 101 
Rh Negative  Outline black  White on black  Figure 33, Page 101 
Rh not specified  Solid black  Not applicable  Figure 34, Page 101 
 
Autologous and directed (dedicated, designated) units that cannot be crossed over 
do not follow the above format to distinguish Rh positive and Rh negative products 
because of the smaller size of the bar code text (see Figure 35 and Figure 36, page 
102). 
 
If the blood product is from an individual of the Bombay or para-Bombay 
phenotype, BOMBAY (O ) or PARA-BOMBAY A  (or B AB , or O ) will be printed 
h h h,  h h
in place of A, B, AB, or O (see Figure 38, page 103). 
 
 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    35 
4.2.1.1  Application 
 
Usually, the ABO/Rh label is the last applied after all testing of the donation 
or collection is complete.  
 
4.2.1.2  Type of Donation or Collection/Intended Use  
 
Information about the type of donation or collection/intended use [e.g., 
Autologous or Directed (Dedicated, Designated) Collection] is to be 
included in the ABO/Rh Blood Groups bar code when the blood product is 
to be used solely for a specific recipient (that is, it cannot be crossed over 
for use by another patient) or used for a special purpose. If the blood 
product is not intended solely for a specific recipient or is not one of the 
special purpose blood products listed in Table 4, Page 39, the default gg 
(n) value for the ABO/Rh blood groups should be used.  
 
The default values of gg are shown as an n value in Table 3, Page 37. 
These n values are used to calculate the appropriate values of gg for 
other units. In the US, these values may be (n4), (n3), (n2), n, (n+2) and 
(n+3).  
 
One value allowed internationally is not used in the US. 
  
  The value (n1) (Directed, Eligible for Crossover) is currently 
not used in the US. This information can be encoded in the 
Product Code, however. 
  
NOTE:  IN THE NEXT VERSION OF THIS DOCUMEN T, n-1 WILL 
LIKELY BE ALLOWED. A FORMAL CHANGE PROCE SS WILL BE 
FOLLOWED TO ENSURE USER INPUT INTO THIS D ECISION. 
 
 
When the blood product is to be used for a specific recipient or for a special 
purpose, the ABO/Rh label should look very different from the appearance 
of a standard allogeneic unit (see Figure 35 and Figure 36, page 102). 
 
If the unit is for autologous use, values n+2 (For autologous use only) or 
n+3 (For autologous use only/Biohazard) will be used. In both cases, the 
label will have FOR AUTOLOGOUS USE ONLY printed below the ABO/Rh 
bar code text as shown in Figure 35, page 102. The international biohazard 
symbol and the word BIOHAZARD will appear before the phrase FOR 
AUTOLOGOUS USE ONLY when n+3 is used. In the US, the value n+1 
(for autologous use, eligible or crossover) is not used routinely because 
AABB Standards preclude the routine crossover of autologous units. US 
software is unlikely to support this option. 
 
If the blood product is a directed, designated, or dedicated donation that is 
intended solely for a specific recipient, the n4 (Directed Only) or n-2 
(Directed Only/Biohazard) values may be used and FOR DESIGNATED 
RECIPIENT ONLY should be printed below the ABO/Rh bar code text as 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    36 
shown in the illustration in Figure 36, page 102. The international biohazard 
symbol and the word BIOHAZARD will appear before FOR DESIGNATED 
RECIPIENT ONLY when n-2 is used. 
 
If the blood product is a directed, designated, or dedicated donation that 
may be crossed over, it should be labeled in the upper right quadrant as a 
routine allogeneic donations (n option). During the time that such a unit is 
reserved for a specific recipient, an intended recipient label or tie tag such 
as the ones illustrated in Figure 100, page 143, should be attached or 
affixed to the unit providing the appropriate information. When released for 
routine use, this label or tie tag should be removed. 
 
If the product is being released by the collection or processing facility prior 
to completion of testing, the n-3 (FOR EMERGENCY USE ONLY) should 
be used. See Figure 77, page 122 for an example. FOR EMERGENCY 
USE ONLY and the name of the patient and hospital where the patient is 
located should be on the label or labeling.  
4.2.2  Rh, Kell, and GP-Mur (Miltenberger III) Phenotypes 
 
As noted above, Rh, Kell, and GP-Mur (Miltenberger III) phenotypes should not be 
encoded as part of the ABO/Rh Blood Groups bar code in the US. 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    37 
 
Table 3  ABO/Rh Blood Groups Data Structure: Values of "gg"  
Note: Shaded column indicates a type of donation (autologous eligible for crossover) that is not commonly used in the US. It is included for the sake 
of completeness since it is not precluded by federal regulations. Software in the US is unlikely to support this option. 
 
       
Default:  Directed  Directed  Autologous   
Intended  (Dedicated/    (Dedicated/  Collection/    For 
Use  Designated)  For  Designated)  Eligible  For  Autologous 
  Not  Collection  Emergency  Collection/  for  Autologous  Use Only/ 
ABO and RhD  Specified  Use Only  Use Only  Biohazard  Crossover  Use Only  Biohazard 
Blood Groups  (n)  (n-4)  (n-3)  (n-2)  (n+1)  (n+2)  (n+3) 
               
O RhD negative  95  91  92  93  96  97  98 
               
O RhD positive  51  47  48  49  52  53  54 
               
A RhD negative  06  02  03  04  07  08  09 
               
A RhD positive  62  58  59  60  63  64  65 
               
B RhD negative  17  13  14  15  18  19  20 
               
B RhD positive  73  69  70  71  74  75  76 
               
AB RhD negative  28  24  25  26  29  30  31 
               
AB RhD positive  84  80  81  82  85  86  87 
               
O  55  P2  P3  P4  P7  P8  P9 
               
A  66  A2  A3  A4  A7  A8  A9 
               
B  77  B2  B3  B4  B7  B8  B9 
               
AB  88  C2  C3  C4  C7  C8  C9 
 
para-Bombay, RhD               
negative  D6  D2  D3  D4  D7  D8  D9 
 
para-Bombay. RhD               
positive  E6  E2  E3  E4  E7  E8  E9 
               
Bombay, RhD negative  G6  G2  G3  G4  G7  G8  G9 
               
Bombay, RhD positive  H6  H2  H3  H4  H7  H8  H9 
O para-Bombay, Rh D 
negative  I6  I2  I3  I4  I7  I8  I9 
O para-Bombay, RhD 
positive  J6  J2  J3  J4  J7  J8  J9 
 
                            
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  US Consensus Standard, Version 3.0.0    38 
       
Default:  Directed  Directed  Autologous   
Intended  (Dedicated/    (Dedicated/  Collection/    For 
Use  Designated)  For  Designated)  Eligible  For  Autologous 
  Not  Collection  Emergency  Collection/  for  Autologous  Use Only/ 
ABO and RhD  Specified  Use Only  Use Only  Biohazard  Crossover  Use Only  Biohazard 
Blood Groups  (n)  (n-4)  (n-3)  (n-2)  (n+1)  (n+2)  (n+3) 
A para-Bombay, RhD 
negative  K6  K2  K3  K4  K7  K8  K9 
B para-Bombay, RhD 
negative  L6  L2  L3  L4  L7  L8  L9 
AB para-Bombay, RhD 
negative  M6  M2  M3  M4  M7  M8  M9 
A para-Bombay, RhD 
positive  N6  N2  N3  N4  N7  N8  N9 
B para-Bombay, RhD 
positive  O6  O2  O3  O4  O7  O8  O9 
AB para-Bombay, RhD 
positive  Q6  Q2  Q3  Q4  Q7  Q8  Q9 
Group A, Pooled Rh 
A0 
[Pooled Products]             
Group B, Pooled Rh 
B0 
[Pooled Products]             
Group AB, Pooled Rh 
C0 
[Pooled Products]             
Group O, Pooled Rh 
D0 
[Pooled Products]             
Pooled ABO, Rh Positive 
E0 
[Pooled Products]             
Pooled ABO, Rh 
Negative [Pooled  F0 
Products]             
Pooled ABO, Pooled Rh 
G0 
[Pooled Products]             
Pooled ABO [Rh not 
specified] [Pooled  H0 
Products]             
 
 
                            
 2013 ICCBBA   All rights reserved   www.iccbba.org 
  US Consensus Standard, Version 3.0.0    39 
Table 4  Values of gg for ABO/Rh Data Structure for Special Purpose Blood Groups 
 
Value of gg    Interpretation 
 
Ma  Autologous collection 
 
Mb  Biohazard 
 
Md  Discard (to be destroyed) 
 
Mf  F or fractionation use only 
Mq  Q uarantine/hold for further testing or processing 
Mr  F or research use only 
 
Mx  Not for transfusion based on test results 
 
 
 
 
 
 
 
 
 
 
 
 
                            
 2013  ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    40 
4.3  Product Code (003) 
       
The Product Code data structure has eight (8) data characters: 
 
ooootds 
where: 
 
oooo  specifies the Product Description Code and is encoded and interpreted by 
reference to the Product Description Code Database table published and 
maintained by ICCBBA in the password-protected area of the ICCBBA 
Website (see 8.2, page 145). 
 currently indicates the following product groups:  
 
 E or F  blood components  
 M   Other Therapies: 
 Human milk - codes beginning with M0 (M0001 to M0999) 
o
 Not assigned - codes beginning with M1 through M8 (M1000 
o
to M8999) 
 Topical use products of human origin - codes beginning with 
o
M9 (M9000 to M9999) 
 N  Partially assigned: 
 Organs for Transplant  codes beginning with N0 (N0001 to 
o
N0999) 
 Not assigned  codes beginning with N1 through N9 (N1000 
o
to N9999) 
 R  Partially assigned 
 Reproductive Tissue  codes beginning  with R0 (R0001 to 
o
R0999) 
 Not assigned  codes beginning with R1 through R9 (R1000 
o
to R9999) 
 S  cellular therapy products  
 T  tissues 
 V  ocular tissue 
 X  derivatives  
 A-D  national or local codes (see below). 
 
oooo can only be interpreted when combined with  through reference to 
the Product Description Code database. 
 
A-D National or Local Codes 
The block of Product Description Codes, A0000-D9999, has been 
reserved for use as nationally or facility defined Product Description 
Codes. There will be no international interpretation associated with these 
values. 
These codes should ONLY be used where there is not an appropriate 
international code and there is good reason why an international code 
 
                            
 2013  ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    41 
ooootds 
where: 
 
should not be allocated. For example, local codes should be used when a 
product is only produced in one or a very small number of facilities. If 
there is any uncertainty about whether the code assigned to a product 
should be international or local/regional/national, the user should contact 
the ICCBBA office. 
National agencies may elect to reserve a range of these values for 
national assignment (see 4.3.1.1 for US Product Description Codes). 
Where this is done it is the responsibility of the national agency to ensure 
that definitions are provided for use within the country and that products 
bearing such codes are not transferred outside the national boundary. 
Individual facilities may also assign codes for their own use provided that 
these do not conflict with codes assigned at the national level. Where 
such codes are used, it is the responsibility of the facility to ensure that 
definitions are provided for use within their service region, and that 
products bearing such codes are not transferred outside their normal 
distribution network. Care will have to be taken in interpreting the product 
description from a local code as this will be specific to the supplier. 
In all cases, the product definition for nationally or facility assigned codes 
must be retained permanently for traceability purposes. Once assigned, 
codes shall not be reassigned. 
  
t    for blood products, designates the type of donation or collection/intended 
use (see Table 9, beginning on page 91); 
 
ds  provides information about divisions of the blood product. 
 
Data characters seven and eight (ds) are reserved for encoding information 
about divisions of blood products. When a blood product is divided into two 
or more parts, the seventh and eighth data characters are changed from 
00 (zero, zero), the default values. See 7.8.3, page 118, for examples of 
how these characters may be used. 
 
The 7th and 8th characters are generally used to indicate divisions when 
less than standard adult doses are involved (i.e., pediatric doses). When a 
donation is divided into multiple adult doses during collection (e.g., 
Apheresis Red Blood cells or Apheresis Platelets), this division is coded as 
part of the Product Description Code. Such an apheresis product could 
subsequently be divided into pediatric aliquots. These subsequent divisions 
into pediatric doses would be coded using the 7th and 8th characters of the 
Product Code (i.e., the Product Description Code could indicate, for 
example, 2nd Container, but there could be an A or B in the seventh position 
if the contents of the 2nd container were subsequently divided into pediatric 
aliquots). 
 
For example: 
 
                            
 2013  ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    42 
E3087 is the Product Description Code for Apheresis 
PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|1st container. The full 
Product Code for a volunteer donor would be E3087V00. 
 
When divided into two pediatric aliquots in a closed system, the Product 
Codes become E3087VA0 and E3087VB0. 
 
Figure 6  Product Code Structure 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.3.1  US Specification 
 
The Product Code must be machine and eye-readable. 
 
The ISBT 128 Product Description Code database is an international data base 
and contains descriptions for blood products that are not used in the US. The 
approval for use of any blood product in the US remains the purview of the FDA. It 
should not be assumed that because a blood product description exists in the 
database that it is acceptable to produce and distribute the blood product within 
the US. 
 
4.3.1.1  National Product Description Codes 
 
In the US, Product Description Codes in the range B7000 through 
B9999 have been reserved for national use. These codes should NOT be 
used for local Product Description Codes. 
 
4.3.1.2  Proper Name 
 
In order to simplify label design in a rules-based system, and to promote 
international harmonization, the proper name of a blood product in the US 
will generally be a reflection of the component Class and Modifiers as they 
appear in the ISBT 128 Product Description Code Database. Some 
exceptions are: 
 
 
                            
 2013  ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    43 
  Plasma for manufacture is either Source Plasma or Recovered 
Plasma; 
  Cryoprecipitate is Cryoprecipitated AHF;  
  Pooled Platelets with bacterial monitoring or bacterial testing following 
FDA guidelines for extension of dating are Pooled Platelets -5d; 
  Red Cells to which plasma has been added are Reconstituted Red 
Blood Cells 
  Leukocytes for manufacture (either apheresis or whole blood derived) 
are Source Leukocytes 
 
Table 5, beginning on page 67, and Table 6, page 73, provide the proper 
names for products in the US.  
  
4.3.1.3  Attributes  
 
Table 7 (beginning on page 74) contains a listing of each Attribute Group 
used in the US (current as of the date of publication of this document) and 
its accompanying text. 
 
4.3.1.4  Type of Donation or Collection/Intended Use  
 
The type of donation or collection/intended use can be encoded in the sixth 
data character of the Product Code bar code. Codes that are acceptable for 
use in the US, as well as the wording of the label text, are shown in Table 9, 
beginning on page 91. 
 
In the US, the following usage is mandatory: 
 
Code  Required for 
V  All blood products intended for transfusion that are collected 
from volunteer allogeneic donors if one of the optional codes is 
not used. 
P  All blood products intended for transfusion that are collected 
from paid donors if one of the optional codes is not used. 
T  Therapeutic collections if they are labeled for transfusion; it is 
not required if the collection is promptly discarded. 
Facilities may also use V rather than T if the facility has been 
granted approval from FDA for an alternative procedure to 21 
CFR 640.3(d) under the provisions of 21 CFR 640.120 to 
distribute Whole Blood and blood components collected from 
individuals with diagnosed hereditary hemochromatosis without 
indicating the donors disorder on the container label. 
X or 1  Blood products collected from autologous donors that are not 
eligible for crossover. 
A  Autologous unit eligible for crossover. However, because this 
crossover of autologous units is not a standard practice in the 
US, software may not be able to support the use of this code. 
 
 
                            
 2013  ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    44 
 
In the US, the following usage is optional: 
 
R, S, D*, 2, 3, 4, or 5 may be used in place of V 
 
  * NOTE:  WHILE THE USE OF D IN THE PRODUCT CODE FOR  
  DIRECTED DONATIONS ELIGIBLE FOR CROSSOVER IS OPTIONAL 
  IN VERSION 3.0.0 OF THE US CONSENSUS STANDARD, IT WILL 
  BECOME MANDATORY WHEN THE NEXT VERSION OF THE US 
  CONSENSUS STANDARD IS PUBLISHED. 
 
r, s, or d may be used in place of P 
 
0 (zero) (meaning not specified) may be used for Recovered Plasma, 
Source Plasma, or Source Leukocytes 
 
When appropriate (see 4th column on Table 9, beginning on page 91) the 
donation or collection type which is encoded in the 6th character of the 
Product Code should be printed immediately below the bar code to the right 
of the required eye-readable information as illustrated in Figure 7. An 
example of an autologous unit is shown in Figure 69, page 111. The 
printing should be the same size and height as the required data content 
text. Bar code text to be printed may be found in Table 9, page 91. 
 
Figure 7  Donation Type Encoded in Product Code      
                          
                                                     
 
 
 
 
 
 
When a unit that is labeled as a directed (or designated or dedicated) is to 
be crossed over, it is the prerogative of the facility to determine if the 
Product Code and the corresponding bar code need to be changed to 
reflect that the product is no longer reserved for the intended recipient. 
 
4.3.1.5  Divisions  
 
The scheme outlined in the ISBT 128 Standard Technical Specification will 
be used for identifying divisions. If the seventh and eighth data characters 
are other than 00, then the term DIVIDED should appear on the label in 
the first Attribute line, followed by Attributes such as IRRADIATED. If 
desired, a notation describing the division number may appear in the text 
below the storage temperature (see Figure 8, page 45).  
 
                            
 2013  ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    45 
 
Figure 8  Labeling of Divisions 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Section 7.8.3 provides examples of how the system may be used to label 
pediatric aliquots. 
 
4.3.1.6  Examples of Labels 
 
Chapter 7 provides examples of labels based on these rules. From these 
illustrations, the logic to be used when designing a blood product 
description label can be seen. It is not intended that this document should 
provide an illustration of every possible combination  there are far too 
many  so it is important that the rules and logic behind the illustrations 
provided be clearly understood. ICCBBA will assist facilities, or their label 
vendors, in designing needed labels. If there are required labels that will 
not fit the logic and rules provided in this document, or when designing 
labels utilizing Classes, Modifiers, or Attributes that did not exist at the time 
of the printing of this document, please contact the ICCBBA office.  
 
4.3.1.7  Obtaining a New Product Description Code             
 
An on-line request form for new Product Description codes may be found 
on the ICCBBA website. Instructions for completion of this form are found 
in Use of Product Code Data Structure [003] - Blood. 
 
                            
 2013  ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    46 
 
4.4   Expiration Date and Time (005) 
 
This data structure has 10 data characters: 
 
cyyjjjhhmm 
 
 
where: 
 
 
c  designates the century (e.g., 0 for 2000; 1 for 2100)   
 
yy  designates the year of expiration 
 
 
is the ordinal (or Julian) date (the number of the day in the year, e.g., 
jjj   
022 is 22 JAN)   
 
hh  is the hour (0023) at which the product expires 
 
 
mm  is the minute at which the product expires (0059) 
 
A day is defined as beginning at midnight (00:00) and ending at 23:59. 
4.4.1  US Specification 
 
The expiration date/time does not have to be machine readable, but this will 
improve process control. The expiration date must appear in text on the label. If the 
dating period for the product is 72 hours or less, the time of expiration must also 
appear on the label. 
 
This format is DD MMM YYYY. For example: 
 
21 JUL 2009 
 
Abbreviations for month are: JAN; FEB; MAR; APR; MAY; JUN; JUL; AUG; SEP; 
OCT; NOV; DEC. 
 
When a product outdates at midnight as a default, the time should be encoded into 
the bar code as 2359 and be displayed in the data content text as 2359, as shown 
in Figure 9. However, the time should not be shown in the bar code text; midnight 
expiration is assumed. (For an explanation of text terminology, see the Glossary.) 
 
                            
 2013  ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    47 
 
Figure 9  Text When Expiration is Default Time of 23:59 
  
 
 2359 appears in 
 data content text 
 beneath bar  Time 23:59 does not 
 code  appear in bar code text 
 
 
 
 
 
 
 
 
If the dating period for the product is 72 hours or less, the time of expiration must 
appear on the label. It should therefore be encoded in the bar code and printed in 
the data content text. In the bar code text, the time should be printed after the date 
with a colon separating hours from minutes in the bar code text. For example: 
 
 
Figure 10  Expiration Date and Time 
 
 
 
1515 appears in 
 
data content text 
 
beneath bar  Time 15:15 appears in 
 
code  bar code text 
 
 
 
 
 
 
 
 
 
 
                            
 2013  ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    48 
 
4.5  Collection Date (006) 
 
This data structure has 6 data characters: 
 
cyyjjj 
Where:   
c  is the century of the year in which the product was collected 
yy  is the year within the century in which the product was collected 
jjj  is the ordinal (or Julian) date on which the product was 
collected 
 
The text is printed as described in 4.4.1. 
4.5.1  US Specification 
 
Collection date is not required to be machine readable, but this would improve 
process control. 
 
Collection dates are not included on most product labels. Collection dates are 
utilized on Source Leukocytes and Recovered Plasma (and may be utilized on 
Source Plasma depending on contract requirements) when collection time is not 
critical.  
 
Figure 11  Collection Date on Recovered Plasma Label 
 
 
                            
 2013  ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    49 
Figure 12  Collection Date on a Product for Transfusion 
 
 
                            
 2013  ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    50 
 
4.6  Collection Date and Time (007) 
 
This data structure has 10 data characters: 
 
cyyjjjhhmm 
where:   
c   is the century of the year in which the product was collected 
yy  is the year within the century in which the product was collected 
jjj  is the ordinal (or Julian) date on which the product was collected 
hh  is the hour at which the product was collected (00 to 23) 
mm  is the minute at which the product was collected (00 to 59) 
 
A day is defined as beginning at midnight (00:00) and ending at 23:59. 
 
4.6.1  US Specification 
 
Collection date and time are not included on most product labels. Collection date 
and time are utilized on Recovered Plasma (and may be utilized on Source Plasma 
depending on contract requirements) when collection time is critical. The text is 
printed as described in 4.4.1.  
 
Collection date and time are not required to be machine readable but this would 
improve process control. 
 
                            
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  US Consensus Standard, Version 3.0.0    51 
4.7  Special Testing: General (010) 
 
An optional ISBT 128-specified data structure has been defined to contain the results of 
special or additional testing (e.g., CMV or Hemoglobin S). The codes appear in the 
Special Testing: General database maintained on the ICCBBA Website. See the ISBT 128 
Standard Technical Specification for details. 
4.7.1  US Specification 
 
Examples of US labeling for this bar code are provided in Figure 66, page 109.  
 
The code N0008 will be used to indicate the product is negative for antibodies to 
CMV based on testing of the current product (i.e., historical results for the donor 
may not be used). The text that will appear with this code is: Anti-CMV Neg. or 
Negative for Antibodies to CMV, or a similar phrase. 
 
Special Testing information is not required to be machine readable. 
 
4.8  Special Testing: Red Blood Cell Antigens (012) 
 
An optional ISBT 128-specified data structure has been defined to contain the results of 
additional testing for red blood cell antigens, as well as CMV, Hemoglobin S, parvovirus 
B19, and IgA in conjunction with red cell antigen results. A description of the coding and 
the reference table can be found in the ISBT 128 Standard Technical Specification. 
4.8.1  US Specification 
 
Examples of US labeling for this bar code are provided in Figure 66 and Figure 67, 
page 109 and Figure 68, page 110. 
 
Red blood cell antigen information is not required to be machine readable. 
 
4.9  Special Testing: Platelet HLA and Platelet-Specific 
Antigens (014) 
 
An optional ISBT 128-specified data structure has been defined to contain the results of 
additional testing for platelet HLA and platelet-specific antigens, as well as CMV and high 
titer anti-A and B in conjunction with these results. A description of the coding and the 
necessary reference tables can be found in the ISBT 128 Standard Technical 
Specification. 
4.9.1  US Specification 
 
US labeling for this bar code should conform to the examples provided in the ISBT 
128 Standard Technical Specification. 
 
Platelet HLA and platelet-specific antigen information is not required to be 
machine readable. 
 
                            
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  US Consensus Standard, Version 3.0.0    52 
5 Uniform Labeling Using ISBT 
128 
 
5.1  Concepts 
5.1.1  Principles of Label Design 
 
To remain within the rules-based system of ISBT 128, the following principles 
apply: 
 
  Primary considerations in label design shall include improving the safety of 
the product and the efficiency of processing/administering. If these two 
considerations conflict, safety shall take precedence over efficiency. 
 
  Critical information on the container shall dominate the label via position 
and prominence and shall take precedence over information that is of little 
importance to the end-user (clinician, nurse, laboratory staff, and other 
hospital personnel). 
 
  The layout of the bar codes applied to primary, collection, satellite, or 
transfer containers shall conform to the quadrant design as outlined in the 
ISBT 128 Standard Technical Specification when space permits as follows:  
 
Upper left:  Donation Identification Number / Collection Date (and 
Time) 
 
Upper right:  ABO/Rh Blood Groups and Type of Donation or 
Collection/Intended Use 
 
Lower left:  Product Code 
 
Lower right: Expiration Date and Time and Special Testing 
 
  An eye-readable representation of the bar code data content shall appear 
beneath each linear bar code symbol on the container. It shall contain all 
data characters within the symbol, but shall not include the data identifier, 
start/stop characters, special characters (shift C, etc.), or the Code 128 
modulo 103 check digit. With the exception of the Donation Identification 
Number, this representation will generally appear left justified with the first 
bar in the symbol. 
 
  Being able to scan bar codes is of paramount importance. Quiet zones and 
bar heights shall conform to the ISBT 128 Standard Technical Specification. 
Bar codes must be positioned to allow use of any of the three common 
scanning technologies: contact wands, hand-held laser readers, and 
charge-coupled devices (CCDs). 
 
 
 
                            
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  US Consensus Standard, Version 3.0.0    53 
 
5.1.2  US Specification for Bar Code Text and Additional Text 
  
In general, this document will defer to the ISBT 128 Standard Technical 
Specification for typeface or type height of text. This will permit changes to occur in 
the ISBT 128 Standard Technical Specification without requiring a change in this 
document.  
 
Text describing the product (Class, Modifiers, Attributes, and Additional 
Information) will be left justified. Other bar code and label text may be centered or 
left justified as appropriate (see illustrations in Chapter 7), with the exception of the 
Donation Identification Number. For the printing of the Donation Identification 
Number, see 4.1.1.2, page 32. The DIN text may be right justified or centered 
under its bar code. 
 
Fonts shall be sans serif. Compressed (condensed) fonts should be used before 
any text is abbreviated. Only approved abbreviations should be used (see the 
Appendix, page 147). 
 
Color 
  The full 13-character Donation Identification Number must be printed in 
the same color (see 4.1.1.2, page 32).  
 
  The Biohazard symbol must be orange if preprinted labels are used, but 
may be black and white if an on-demand printer is used (see 5.1.3.3, 
page 58). 
 
  The use of color for ABO/Rh or other labeling is neither prohibited nor 
encouraged.  
 
The US License Number may be printed in either of two locations: the upper left 
quadrant or the lower left quadrant. It must not be printed in both locations. A US 
License Number is only applied by licensed facilities to blood products they are 
licensed to produce; a US License Number must not appear on unlicensed blood 
products. 
 
Text shown in example labels and on various tables in this document represents 
ICCBBAs recommendations. Other variations of the wording, capitalization, or 
punctuation may also be acceptable. Users are advised to consult the FDA to 
determine if a proposed variation is acceptable. 
5.1.3  Label Design 
 
In applying these principles the design and arrangement for US labels is 
predicated on the following:  
 
  The base label of primary collection, and satellite containers shall be 100 
mm [4"] wide and 108 mm [4.25"] long 
 
 
                            
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  US Consensus Standard, Version 3.0.0    54 
  The design of the final label shall cover an area 100 mm [4"] wide by 100 
mm [4"] long 
 
  Each 100 mm [4"] wide by 100 mm [4"] long label shall be divided into 
four equal 50 mm [2"] wide by 50 mm [2"] long quadrants 
 
  The placement of the bar codes [Donation Identification Number, 
ABO/Rh Blood Groups, Product Code, Expiration Date and Time, and 
Special Testing] shall conform to the ISBT 128 Standard Technical 
Specification as illustrated in Figure 13, page 55 
 
  Collection date, if included, shall be printed in the lower half of the upper 
left quadrant above VOLUNTEER DONOR or PAID DONOR 
 
  Horizontal lines on base labels and on-demand labels are permitted to 
facilitate label application and reading 
 
  Vertical lines are not permitted where they may interfere with the reading 
of concatenated bar codes. This means there shall be no vertical lines 
printed between the Donation Identification Number and ABO/Rh Blood 
Groups or the Product Code and Expiration Date and Time bar codes 
 
  Although the satellite container is usually smaller, it is possible to apply 
labels of the same size as those used on the primary container 
 
In specifying the print height and position of information to be used in labeling 
blood products, the following order of importance was used: 
 
  Greatest importance: Donation Identification Number and the ABO/Rh 
Blood Group 
 
  Intermediate importance: Expiration Date and Time, Product Description, 
and Volunteer Donor or Paid Donor statement 
 
  Least importance: All other bar code and additional text 
 
Note: No specifications are provided in this document for final labeling of pediatric 
doses of blood products. When consensus is reached for standardized labeling of 
these products, specifications will be included in future versions of this document. 
Until then, labeling of these containers should conform to the principles of 
ISBT128 labeling. 
 
 
 
 
 
 
 
 
                            
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  US Consensus Standard, Version 3.0.0    55 
 
Figure 13  Final Label--Four Equally-Sized Labeling Quadrants: Placement of the Bar Codes 
 
 
ABO/Rh Blood Groups 
Donation Identification Number 
 
   
 
 
 
   
Collection Date (wh en used) 
Donation Type (VOLUNTEER 
OR PAID) 
 
 
 
  Expiration Date 
Product Code 
and Time 
     
Special Testing 
 
     
Container Manufacturers ID  Container Manufacturers 
and Catalog Number   Lot Number  
5.1.3.1  Upper Left Quadrant 
 
The Donation Identification Number will be printed as described in 4.1.1.2, 
page 32.  
 
The text information about the facility that collected (or pooled) the unit 
shall be printed below the DIN. This should include the full legal name of 
the facility and its location (city and state). The name printed in this location 
shall correspond to the Facility Identification Number in the Donation 
Identification Number above it. The FDA registration number may be 
printed in this quadrant.  
 
Generally, the name of the facility is printed in title case (mixture of upper 
and lower case). For example:  
 
Accurate Blood Center 
 
However, if the facility has a doing business as (dba) name, then the legal 
name is printed in all capital letters, and the dba name is printed in title case. 
For example: 
 
 
 
                            
 2013 ICCBBA All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    56 
ACCURATE BLOOD CENTER 
dba Midwest Community Blood Center 
 
In Figure 14, page 56, the US License Number of the facility is shown in 
one of the two acceptable locations.  
 
  See Figure 17, page 58, for the other acceptable location for the US 
License Number. 
  See Section 7.8.18 for details on when the FDA License Number 
should appear on products collected by one facility and modified by 
another. 
 
The required warning label text shall be printed in the lower third of this 
quadrant on blood components intended for transfusion. This text is: 
 
  Properly identify intended recipient. 
  See circular of information for indications, contraindications, 
cautions, and methods of infusion. 
  This product may transmit infectious agents. 
  Rx only 
 
For details on punctuation, consult the Code of Federal Regulations (CFR) 
or your FDA Consumer Safety Officer. Punctuation indicated in the CFR 
takes precedence over examples in this document. 
 
There is no requirement for the size of this text, but it should be as large as 
space allows. 
 
For products intended for transfusion, VOLUNTEER DONOR (or PAID 
DONOR) shall be printed at the bottom of the quadrant in no less 
prominence than the product name. If a collection date appears, it should 
be printed above VOLUNTEER DONOR (or PAID DONOR). See Figure 15, 
page 57. 
 
Figure 14  Upper Left Quadrant--Standard 
 
 
       
 
 
 
 
 
 
 
 
 
                            
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  US Consensus Standard, Version 3.0.0    57 
 
Figure 15  Upper Left Quadrant with Text Collection Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Source Leukocytes, Recovered Plasma, and Source Plasma labels do not 
require the same label text as components intended for transfusion. Source 
Leukocyte and Recovered Plasma labels do, however, require the 
Collection Date, and Source Plasma labels may require a Collection Date 
depending on contract requirements. This date should appear in the lower 
half of this quadrant in place of the warning text required when a product is 
intended for transfusion. 
 
Figure 16  Upper Left Quadrant  Recovered Plasma 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                            
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  US Consensus Standard, Version 3.0.0    58 
5.1.3.2  Lower Left Quadrant 
 
Printing of this quadrant is covered in detail in Chapter 6. 
 
The US License Number is shown in the other acceptable location in the 
illustration below. Applying the US license number in this location will allow 
it to be easily over-labeled if the product is modified into a non-licensed 
product.  
  See Figure 14, Page 56, for the other acceptable location for the US 
License Number. 
  See Section 7.8.18 for details on when the FDA License Number 
should appear on products collected by one facility and modified by 
another. 
 
Figure 17  Lower Left Quadrant 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.1.3.3  Upper Right Quadrant 
 
The ABO/Rh Blood Groups label text may be printed as large as space 
allows. 
 
If the unit is an autologous collection and not eligible for crossover because 
it was obtained from an unsuitable donor (21 CFR 610.40 and 21 CFR 
640.3), FOR AUTOLOGOUS USE ONLY shall be printed at the bottom of 
the quadrant. 
   
Note: If the unit is eligible for crossover because it was obtained from a 
suitable donor, AUTOLOGOUS DONOR shall be printed at the bottom of 
the quadrant (instead of FOR AUTOLOGOUS USE ONLY). However, 
because crossover of autologous units is not routinely performed in the US, 
software may not support this option. Facilities may choose to continue to 
label all autologous donations FOR AUTOLOGOUS USE ONLY and not 
crossover any autologous units obtained from suitable donors. 
 
If an allogeneic unit is designated solely for a specific recipient, FOR 
DESIGNATED RECIPIENT ONLY shall be printed at the bottom of the 
 
                            
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  US Consensus Standard, Version 3.0.0    59 
quadrant (see illustrations in Figure 36, page 102) (see also 5.1.4.1, page 
61). 
 
In either of the latter two cases, the ABO/Rh label text should be very 
different as shown in the illustrations. If the unit is biohazard, the biohazard 
symbol with the word BIOHAZARD beneath it shall also appear in this 
quadrant (see Figure 18, page 59). OSHA permits the biohazard label to be 
black on white when produced by an on-demand printer as part of the 
ABO/Rh label. This does not preclude the use of the familiar orange 
biohazard label, and the orange label is still required for preprinted labels. 
 
Figure 18  Upper Right Quadrant 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.1.3.4  Lower Right Quadrant 
 
The Expiration Date and Time bar code and the bar code text shall appear 
in the upper third of this quadrant. The label text Expiration Date (and Time) 
may be printed to the right of the bar code; the bar code text (e.g., 01 JAN 
2005 14:00) shall be printed below the bar code. The standard 
representation of date shall be DD MMM YYYY and the standard 
representation for time shall be HH MM. The local time (if other than the 
default 23:59) shall be printed in 24-hour format with a colon. As noted on 
Figure 9 page 47, if the expiration time is coded as the default 23:59, no bar 
code text relating to time should appear. 
 
The name, location, and FDA registration number (and FDA license 
number, if applicable) of a modifying facility, if different from the collection 
facility, shall appear in the bottom half of this quadrant. This information is 
not required if: 
  The product is shipped to another facility operating under the same 
FDA license  
  The product is not distributed outside the facility in which it was 
modified 
  A contractor of the firm performs the product modification 
 
This information does not have to be machine readable.  
 
 
                            
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If the product does not leave the facility in which it was modified, the 
identification of the facility that modified the product is not required, but may 
be included if the facility chooses to do so.  
 
Special Testing information (if any of these optional bar codes are used) 
should be printed in the middle of this quadrant.  
 
Additional text for the presence of red cell antibodies may appear in this 
quadrant. 
 
Figure 19  Lower Right Quadrant for Product Leaving the Facility 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
If allogeneic blood has not been tested for the required infectious markers, 
either (1) the results of infectious disease markers that have been 
performed and indication of which tests have not been completed shall 
appear on the affixed label or (2) this information shall appear on a tie tag 
and a phrase such as SEE TIE TAG FOR TEST RESULT INFORMATION 
should appear in this quadrant (see Figure 20).  
 
Similarly, the message DONOR TESTED WITHIN THE LAST 30 DAYS 
should appear in this quadrant, when appropriate for a dedicated donor [21 
CFR 610.40 (c)(1)(ii)] or an autologous donor [21 CFR 610.40 (d)(4)]. 
 
Figure 20  Lower Right Quadrant for Incompletely Tested Allogeneic Units 
 
 
 
 
 
 
 
 
                            
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  US Consensus Standard, Version 3.0.0    61 
 
For untested autologous units, 21 CFR 610.40(d)(4) requires the phrase 
DONOR UNTESTED to appear on the label. This phrase should appear 
in the lower right quadrant. 
 
Figure 21  Donor Untested Label for Autologous Units 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
For Source Leukocytes, if the product is released before completion of testing for 
infectious markers, the label must include the statement:  
 
Caution: Do not use contents until test results for HBsAg, STS, 
HCV RNA, HIV-1 RNA, HBV DNA, and antibodies to HIV, HCV, and 
HTLV-I/II have been received from the collection facility. 
5.1.4  Additional Labels 
5.1.4.1  Intended Recipient Labels 
 
The identification of the intended recipient of a directed, autologous, 
designated, or dedicated collection may appear either on an affixed label 
on the container or on a tie tag. A label having the dimensions of no less 
than 65 mm [2.5"] by 25 mm [1"] long should be used, and if used as a label 
on the container, should not cover any other labeling. The label should 
have INTENDED RECIPIENT INFORMATION LABEL [21 CFR 
610.40(c)(1)(ii)] printed on it. The remainder of the label should be 
arranged so that space is provided for the patients name, identification 
(e.g., medical record) number, birth date, the name of the hospital, and 
other information as shown in Figure 100, page 143. 
 
Note: On a platelet storage container it may be inappropriate to place a 
label in the area above the base label because it reduces the breathable 
area for platelet storage and could result in decreased platelet viability. 
Please consult the manufacturer of the container for guidance. 
 
 
 
                            
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  US Consensus Standard, Version 3.0.0    62 
5.1.4.2  Emergency Release Labels 
 
When a unit is released before testing is completed, an additional label 
(either on an affixed label on the container or on a tie tag) shall indicate 
which tests have and have not been completed. For one possible design of 
such a tie tag, see Figure 101, page 144.
 
                            
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  US Consensus Standard, Version 3.0.0    63 
 
6 Printing ISBT 128 Product 
Description Labels 
 
This chapter provides instructions for printing ISBT 128 product description labels for the most 
common blood products.  
 
6.1  Rules for Printing ISBT 128 Product Description 
Label Text 
 
Illustrations in this document follow a rules-based system for printing product description 
label text. In the US, these system rules reflect FDA requirements and are intended to 
present the needed information with as little abbreviation as possible given the constraints 
imposed by label size.  
 
This chapter covers general rules. Instructions for products that may not follow the general 
rules are found in Section 7.8, beginning on page 112. 
 
The general rules are: 
 
  The ISBT 128 product description label design is based on a Component Class (Red 
Blood Cells, Whole Blood, Plasma, Platelets, etc.), a Modifier (Washed, Frozen, etc.), 
and Attributes (Irradiated, Leukocytes Reduced, etc.). The Component Class may be 
printed as large as space allows (not exceeding 4 mm [5/32"] in height).  
 
The standard positioning scheme is: 
 
MODIFIER 
COMPONENT CLASS (or PROPER NAME if different) 
ATTRIBUTE(S) 
 
  The text size of Modifiers should be proportionally smaller than the Component Class 
(or proper name, if different) of the blood product unless otherwise specified in the 
CFR. 
 
  The text size of the Attributes should be proportionately smaller than the text size of 
the Modifiers unless otherwise specified in the CFR. 
 
  Proper names, if different from Component Class (e.g., SOURCE PLASMA), shall be 
printed in the same manner as Component Class. 
 
  Class (or proper name if different), Modifiers, and Attributes should be printed in all 
upper case letters. 
 
 
                            
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  US Consensus Standard, Version 3.0.0    64 
  Modifiers shall be printed on the line above the Component Class unless the additional 
text is such that abbreviation of the proper name would be necessary. In this case, the 
proper name can begin on the first line immediately after the Modifier(s) and wrap to 
the second line. Size difference should be maintained. See Figure 23, page 65. 
 
  In general, Modifiers should be applied in reverse order of the procedures performed. 
For example, red blood cells are rejuvenated before they are frozen, so the correct 
order for the Modifiers is Frozen Rejuvenated. 
 
  Additive solutions shall be listed on the line immediately after the Component Class (or 
proper name if different) and before the intended use cautionary statement, if 
applicable.  
 
  Intended use information (in the form of a cautionary statement such as CAUTION: 
FOR USE IN MANUFACTURING NONINJECTABLE PRODUCTS ONLY) shall be 
printed the same size as the proper name and on the lines immediately following the 
proper name. 
 
  If the unit is divided, DIVIDED shall appear before Attributes (see 4.3.1.5, page 44). 
 
  Attributes shall be printed on the lines below the Component Class (or proper name, if 
different) and below the additive and the word DIVIDED, if present. If an additive and 
DIVIDED are not present, Attributes may be printed beginning immediately after the 
Component Class if space considerations dictate. Size difference should be 
maintained. Attributes shall appear in the same order as the Attribute Groups as listed 
in Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions 
(or as listed in the Product Description Code Database).  
 
  Whenever the volume is shown (____ mL), it shall appear on the first line below the 
Attributes (the first Additional Information line). 
 
  Anticoagulants and nominal collection volume (for example, From 450 mL CPD Whole 
Blood) shall be shown in the Additional Information lines, when appropriate.     
 
Figure 22  Printing of Anticoagulant and Storage Temperature on Label 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Storage temperature shall be printed below the anticoagulant and nominal collection 
volume (when present).  
 
                            
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  US Consensus Standard, Version 3.0.0    65 
 
  Container and division text may optionally appear beneath the storage temperature if 
space permits. See Figure 50, page 105. 
 
  The US License Number, when appearing in the lower left quadrant, is on the last 
Additional Information line. See Figure 50, page 105. 
 
  Provided that small fonts are used, there is usually sufficient space to avoid 
abbreviation of any label or additional text with the exception of common abbreviations 
such as mL for milliliter(s) and C for degrees Celsius (Centigrade). Should 
abbreviations be absolutely necessary, they should conform to those listed in the 
Appendix. If there is no appropriate abbreviation in the Appendix, please consult the 
ICCBBA office for approval of the proposed abbreviation. ICCBBA will consult with the 
FDA and, if the abbreviation is acceptable, add it to the Appendix. 
 
  In general, the position of the bar code, data content text, and the Component Class 
(or proper name, if different) are fixed. Modifiers, Attributes, and Additional Information 
are placed in relation to the Component Class (or proper name, if different). 
 
Figure 23  Printing of Product Description Labels 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
As can be seen from the two illustrations above, this placement generally permits a 
maximum of four (4) lines for Attributes and four (4) lines for Additional Information.  
 
The Component Class (or proper name if different) should be placed above the middle of 
the label, as shown, and left justified. The size of the Component Class (or proper name if 
different) should be as large as possible (maximum height 4 mm [5/32"]), remembering 
that VOLUNTEER DONOR must be no less prominent. A compressed font that permits 
the height of the font to remain as large as possible is preferable to using a font that 
necessitates decreasing the height of the font. 
 
Note: Combining two statements on a single line for Attributes or Additional Information is 
acceptable and saves considerable space, provided that the reading of the statements is 
not compromised and that the general order of the statements is not changed. See Figure 
24. 
 
 
                            
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  US Consensus Standard, Version 3.0.0    66 
Figure 24  Two Attribute Statements on a Single Line 
 
 
                            
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  US Consensus Standard, Version 3.0.0    67 
6.2  Proper Names of Products 
 
Note: The inclusion of a product in this chart does not necessarily mean that the product is an FDA-licensable product. 
 
Table 5  Proper Name (Based on Class and Modifier) 
 
 
     
Modifier  Component Class   Proper Name 
     
  WHOLE BLOOD   WHOLE BLOOD 
     
  RED BLOOD CELLS  RED BLOOD CELLS 
 
    WASHED 
RED BLOOD CELLS 
WASHED  RED BLOOD CELLS 
 
    FROZEN 
RED BLOOD CELLS 
FROZEN  RED BLOOD CELLS 
 
    FROZEN REJUVENATED 
RED BLOOD CELLS 
FROZEN REJUVENATED  RED BLOOD CELLS 
 
    DEGLYCEROLIZED 
RED BLOOD CELLS 
DEGLYCEROLIZED  RED BLOOD CELLS 
 
    DEGLYCEROLIZED 
RED BLOOD CELLS  REJUVENATED 
DEGLYCEROLIZED REJUVENATED 
RED BLOOD CELLS 
 
    REJUVENATED 
RED BLOOD CELLS 
REJUVENATED  RED BLOOD CELLS 
 
 
APHERESIS 
APHERESIS  RED BLOOD CELLS  
RED BLOOD CELLS 
WASHED APHERESIS 
WASHED APHERESIS  RED BLOOD CELLS  RED BLOOD CELLS 
FROZEN APHERESIS 
FROZEN APHERESIS  RED BLOOD CELLS  RED BLOOD CELLS 
FROZEN REJUVENATED 
FROZEN REJUVENATED APHERESIS  RED BLOOD CELLS  APHERESIS  
RED BLOOD CELLS 
DEGLYCEROLIZED APHERESIS 
DEGLYCEROLIZED APHERESIS  RED BLOOD CELLS  RED BLOOD CELLS 
 
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  US Consensus Standard, Version 3.0.0    68 
     
Modifier  Component Class   Proper Name 
DEGLYCEROLIZED 
DEGLYCEROLIZED REJUVENATED APHERESIS  RED BLOOD CELLS  REJUVENATED APHERESIS 
RED BLOOD CELLS 
REJUVENATED APHERESIS 
REJUVENATED APHERESIS  RED BLOOD CELLS  RED BLOOD CELLS 
 
FRESH FROZEN PLASMA 
 
  FRESH FROZEN PLASMA  If the product is to be used for 
further manufacturing, it will 
be labeled: 
RECOVERED PLASMA 
 
THAWED 
FRESH FROZEN PLASMA 
 
   
FRESH FROZEN PLASMA  If the product is to be used for 
THAWED 
further manufacturing, it will 
be labeled: 
RECOVERED PLASMA 
 
APHERESIS 
FRESH FROZEN PLASMA 
 
If the product was collected for 
   
FRESH FROZEN PLASMA  transfusion, outdated, and 
APHERESIS 
then was converted for 
manufacturing use, it will be 
labeled: 
RECOVERED PLASMA 
 
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  US Consensus Standard, Version 3.0.0    69 
     
Modifier  Component Class   Proper Name 
 
THAWED APHERESIS 
FRESH FROZEN PLASMA 
 
    If the product was collected for 
THAWED APHERESIS  FRESH FROZEN PLASMA  transfusion, outdated, and 
then was converted for 
manufacturing use, it will be 
labeled: 
RECOVERED PLASMA 
 
THAWED APHERESIS  
PLASMA 
 
    If the product was collected for 
PLASMA 
THAWED APHERESIS  transfusion, outdated, and 
then was converted for 
manufacturing use, it will be 
labeled: 
RECOVERED PLASMA 
 
LIQUID APHERESIS  
PLASMA 
 
    If the product was collected for 
LIQUID APHERESIS  PLASMA  transfusion, outdated, and 
then was converted for 
manufacturing use, it will be 
labeled: 
RECOVERED PLASMA 
 
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  US Consensus Standard, Version 3.0.0    70 
     
Modifier  Component Class   Proper Name 
 
PLASMA 
 
   
PLASMA  If the product is to be used for 
 
further manufacturing, it will 
be labeled: 
RECOVERED PLASMA 
 
THAWED 
PLASMA 
 
   
THAWED  PLASMA  If the product is to be used for 
further manufacturing, it will 
be labeled: 
RECOVERED PLASMA 
 
LIQUID 
PLASMA 
 
   
LIQUID  PLASMA  If the product is to be used for 
further manufacturing, it will 
be labeled: 
RECOVERED PLASMA 
 
    PLATELET-RICH  
PLATELET-RICH PLASMA 
 
PLASMA 
   
  POOLED PLASMA  POOLED PLASMA 
     
PLATELETS  PLATELETS 
 
 
    WASHED 
PLATELETS 
WASHED  PLATELETS 
     
POOLED PLATELETS  POOLED PLATELETS 
 
 
    WASHED 
POOLED PLATELETS 
WASHED   POOLED PLATELETS 
 
    APHERESIS  
PLATELETS 
APHERESIS  PLATELETS 
 
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  US Consensus Standard, Version 3.0.0    71 
     
Modifier  Component Class   Proper Name 
 
    FROZEN APHERESIS 
PLATELETS 
FROZEN APHERESIS  PLATELETS 
 
    THAWED APHERESIS 
PLATELETS 
THAWED APHERESIS  PLATELETS 
 
    WASHED APHERESIS 
PLATELETS 
WASHED APHERESIS  PLATELETS 
     
CRYOPRECIPITATE   CRYOPRECIPITATED AHF 
 
 
    THAWED 
CRYOPRECIPITATE 
THAWED  CRYOPRECIPITATED AHF 
 
    POOLED 
POOLED CRYOPRECIPITATE 
  CRYOPRECIPITATED AHF 
 
    THAWED POOLED 
POOLED CRYOPRECIPITATE 
THAWED   CRYOPRECIPITATED AHF 
     
GRANULOCYTES  GRANULOCYTES 
 
 
    APHERESIS  
GRANULOCYTES 
APHERESIS   GRANULOCYTES 
     
POOLED GRANULOCYTES  POOLED GRANULOCYTES 
 
   
  GRANULOCYTES/  APHERESIS 
GRANULOCYTES/ 
APHERESIS  PLATELETS  PLATELETS 
 
LEUKOCYTES 
    If the product is to be used for 
LEUKOCYTES  further manufacturing, it will 
 
be labeled: 
SOURCE LEUKOCYTES 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    72 
     
Modifier  Component Class   Proper Name 
 
APHERESIS  
LEUKOCYTES 
    If the product is to be used for 
LEUKOCYTES 
APHERESIS  further manufacturing, it will 
be labeled: 
SOURCE LEUKOCYTES 
             
 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    73 
 
In a few situations, the proper name is based on the Component Class and an Attribute. These situations are: 
 
Table 6  Proper Name (Based on Class and Attribute) 
 
Component Class  Attribute  Proper Name 
RED BLOOD CELLS  Plasma added  RECONSTITUTED RED 
BLOOD CELLS 
POOLED PLATELETS  Bacterial Test or Bacterial  POOLED PLATELETS -5d 
Monitoring 
PLASMA   For manufacture  RECOVERED PLASMA 
APHERESIS PLASMA (when collected for  For manufacture  SOURCE PLASMA 
further manufacturing) 
APHERESIS PLASMA (when collected for  For manufacture  RECOVERED PLASMA 
transfusion, but outdated and converted to 
plasma for further manufacturing) 
APHERESIS LEUKOCYTES and  For manufacture  SOURCE LEUKOCYTES 
LEUKOCYTES 
 
 
The proper name of one product is based on a combination of its Class (Plasma), Attribute (for further manufacturing, 
noninjectable) and its donation type (therapeutic). The proper name of this product is Therapeutic Exchange Plasma (Federal 
Register/Vol 48, No. 64/Friday, April 1, 1983/Notices). An example of a label for this product is seen in Figure 98.  
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    74 
6.3  Attribute Text 
 
Table 7  Attribute Text 
Note: Default values are associated with all Attribute Groups except Core Conditions. The label 
text accompanying a default value, such as FOR TRANSFUSION, NOT IRRADIATED, etc., is not 
printed on the label. Unless otherwise indicated, the default value is assumed.  
 
     
Attribute Group  Attribute Variable  US Labeling Instructions 
Information associated with these variables 
shall be printed in the Additional 
Information Section of the lower left 
quadrant as required by the CFR. 
 
 
Anticoagulant and additive if 
present  Exceptions: Additive text such as 
 
Core Conditions  Nominal volume of original  ADENINE-SALINE (AS-1) ADDED or 
collection  
ADENINE-SALINE (AS-3) ADDED or 
Recommended storage 
ADENINE-SALINE (AS-5) ADDED or 
temperature 
PAS - C ADDED 
shall be printed in the Attribute Section on 
the line following the Component Class. 
CAUTION: FOR MANUFACTURING USE 
 
 
ONLY shall be printed in the Attribute 
  Section on the lines following the Proper 
For further manufacture  
Name in the same font and print size as the 
injectable 
Intended Use 
Proper Name. 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org  US Consensus Standard, Version 3.0.0    75 
     
Attribute Group  Attribute Variable  US Labeling Instructions 
 
CAUTION: FOR USE IN 
  MANUFACTURING NONINJECTABLE 
PRODUCTS ONLY shall be printed in the 
 
Attribute Section on the lines following the 
  Proper Name in the same font and print size 
as the Proper Name. 
 
or 
 
 
CAUTION: FOR FURTHER 
  For further manufacture  
MANUFACTURING INTO IN VITRO 
noninjectable 
  DIAGNOSTIC REAGENTS FOR WHICH 
THERE ARE NO ALTERNATIVE 
 
SOURCES 
 
shall be printed in the Attribute Section on 
  the lines following the Proper Name in the 
same font and print size as the Proper Name 
 
if the unit has a reactive test for an infectious 
  disease or if anti-HBc was not performed. 
 
CAUTION: FOR USE IN 
 
MANUFACTURING NONINJECTABLE 
  PRODUCTS ONLY shall be printed in the 
Attribute Section on the lines following the 
   
Proper Name in the same font and print size 
Intended Use    as the Proper Name. Below this, Not for 
Use in Products Subject to License Under 
   
Section 351 of the Public Health Service 
    Act shall appear. 
   
Or, if intended for use in a product that will 
    be used as a reagent: 
    CAUTION: FOR FURTHER 
MANUFACTURING INTO IN VITRO 
  For further manufacture  
DIAGNOSTIC REAGENTS FOR WHICH 
noninjectable restricted use 
  THERE ARE NO ALTERNATIVE 
  SOURCES shall be printed in the Attribute 
 
Section on the lines following the Proper 
 
  Name in the same font and print size as the 
  Proper Name if the unit has a reactive test 
 
for an infectious disease or if anti-HBc was 
 
  not performed. Below this, Not for Use in 
  Products Subject to License Under Section 
 
351 of the Public Health Service Act shall 
 
  appear. 
 
Or, if intended for use in a product that will 
 
be used as a medical device: 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org  US Consensus Standard, Version 3.0.0    76 
     
Attribute Group  Attribute Variable  US Labeling Instructions 
  CAUTION: FOR FURTHER 
MANUFACTURING USE AS A 
 
COMPONENT OF A MEDICAL DEVICE 
  FOR WHICH THERE ARE NO 
ALTERNATIVE SOURCES shall be printed 
 
in the Attribute Section on the lines 
  following the Proper Name in the same font 
and print size as the Proper Name. Below 
 
this, Not for Use in Products Subject to 
  License Under Section 351 of the Public 
Intended Use 
Health Service Act shall appear.  
 
  CAUTION: FOR MANUFACTURING USE 
ONLY shall be printed in the Attribute 
 
Section on the lines following the Proper 
 
For further manufacture   Name in the same font and print size as the 
  injectable restricted use  Proper Name. Below this, Not for Use in 
Products Subject to License Under Section 
 
351 of the Public Health Service Act shall 
  appear. 
 
Not for transfusion or further  CAUTION: FOR LABORATORY 
  manufacture  RESEARCH USE ONLY 
  shall be printed in the Attribute Section on 
the lines following the Component Class (or 
 
proper name if different) in the same font 
  and print size as the Component Class (or 
proper name if different). 
 
OPEN SYSTEM shall be printed below the 
System Integrity  Open 
Component Class in the Attribute Section. 
IRRADIATED shall be printed below the 
Component Class in the Attribute Section. 
Irradiation  Irradiated 
No abbreviation is permitted. 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org  US Consensus Standard, Version 3.0.0    77 
     
Attribute Group  Attribute Variable  US Labeling Instructions 
LEUKOCYTES REDUCED shall be printed 
Residual leukocyte content 
<5 x 106  below the Component Class in the 
Attribute Section. 
  (ResLeu:<5E6) 
Note: Printing the actual number of 
 
 
leukocytes in the product is optional and is 
Residual  not recommended. If it is printed, it should 
 
Leukocyte Content  appear beneath the storage temperature of 
 
the product 
 
  LEUKOCYTES REDUCED shall be printed 
below the Component Class in the 
  For PLATELETS prepared 
Attribute Section. 
from WHOLE  BLOOD 
 
Note: Printing the actual number of 
Residual leukocyte content 
  <8.3 x 105  leukoocytes in the product is optional and is 
not recommended. If it is printed, it should 
(ResLeu:<8.3E5) 
appear beneath the storage temperature of 
the product. 
Albumin added  ALBUMIN ADDED shall be in Attribute line. 
CRYOPRECIPITATE REDUCED shall be in 
Cryoprecipitate reduced 
Attribute line. 
Name of a red cell product to which plasma 
has been added shall be RECONSTITUTED 
Plasma added 
RED BLOOD CELLS. 
PLASMA ADDED shall be in Attribute line. 
PLASMA REDUCED shall be in Attribute 
Plasma reduced 
line. 
Altered  Plasma reduced/Albumin  PLASMA REDUCED/ ALBUMIN ADDED 
added  shall be in Attribute line. 
Name of a red cell product to which plasma 
has been added shall be RECONSTITUTED 
Plasma reduced/Plasma 
RED BLOOD CELLS. 
added 
PLASMA REDUCED/ PLASMA ADDED 
shall be in Attribute line. 
PLATELETS REDUCED shall be in Attribute 
Platelets reduced 
line. 
SUPERNATANT REDUCED shall be in 
Supernatant reduced 
Attribute line. 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org  US Consensus Standard, Version 3.0.0    78 
     
Attribute Group  Attribute Variable  US Labeling Instructions 
Name of product shall be 
Supernatant  RECONSTITUTED RED BLOOD CELLS. 
removed/Plasma added 
SUPERNATANT REMOVED/PLASMA 
ADDED shall be in Attribute line. 
PLATELETS and 
Platelets/Cryoprecipitate 
CRYOPRECIPITATE REDUCED shall be in 
reduced 
Attribute line. 
LOW VOLUME shall be printed in the 
Attribute Section. 
 
For WHOLE BLOOD: 
 
Approx ___ mL Whole Blood containing 
 
approx ___mL [anticoagulant] should 
  appear on the first line of the Additional 
Information Section providing volumes as 
 
appropriate. 
 
(The volume of the product should be in the 
  first blank; the volume of the anticoagulant 
should be in the second blank.) 
 
 
 
For RED CELLS: 
 
  Approx ___ mL from ___ mL Whole Blood 
 
containing approx ___ mL [anticoagulant] 
Final Content  
Low volume  should appear on the first line of the 
Additional Information Section providing 
 
volumes as appropriate. 
 
(The volume of the product should be in the 
  first blank; the volume of the whole blood 
collection should be in the second blank; the 
 
volume of the anticoagulant should be in the 
third blank.) 
Final content <200 mL 
Final content 200 mL <400 
mL 
Actual volume shall be printed as _____ mL 
Final content 400 mL <600  in the Additional Information Section.  
mL 
Final content 600 mL 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org  US Consensus Standard, Version 3.0.0    79 
     
Attribute Group  Attribute Variable  US Labeling Instructions 
Print in the Attribute Section 
Plasma frozen X hours 
FROZEN WITHIN X HOURS AFTER 
X=15, 24, 48, 72, 120 or 
PHLEBOTOMY  
other number of hours 
(Note: This Attribute is used primarily for 
 
Recovered or Source plasma.) 
  ___ mL Hydroxyethyl Starch Solution in the 
Additional Information Section together 
Preparation: 
  with any anticoagulant present. For 
Additional 
example, ____ mL Na Citrate in 6% 
Information  Granulocytes prepared 
Hydroxyethyl Starch Solution. 
using HES          
 
The percentage of the HES solution is 
  optional. 
 
FROZEN WITHIN 24 HOURS AFTER 
  PHLEBOTOMY 
RT<=24h frozen <=24h 
HELD AT ROOM TEMPERATURE UP TO 
24 HOURS AFTER PHLEBOTOMY 
HELD AT ROOM TEMPERATURE UP TO 
RT<=24h refg 
24 HOURS AFTER PHLEBOTOMY 
1st Container (or 1st Container), 2nd 
1st container, 2nd container,  Container (or 2nd Container), etc., may be 
Apheresis and  etc.  printed beneath the storage temperature in 
container:  the Additional Information section. 
Additional 
Information  Prepared by a manual procedure should be 
Apheresis not automated  printed in the Additional Information 
Section. 
Quarantine: 
Additional    Not used in the US at this time. 
Information 
CONTAINS APPROX   ____ X 1011 
  PLATELETS shall be printed in the 
Additional Information section. (Note: 
Dosage: Additional  <3E11 plts 
Some printers cannot print superscripts. In 
Information 
this situation, CONTAINS APPROX ___E11 
PLATELETS is acceptable.) 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org  US Consensus Standard, Version 3.0.0    80 
     
Attribute Group  Attribute Variable  US Labeling Instructions 
Indicate number of donor units in the pooled 
X units 
product in the Additional Information 
(X number of units) 
section. 
 
Method of 
Not used in the US at this time. 
Treatment   
Either the range may be printed or the actual 
hematocrit may appear on the label in the 
0.5-0.6 
Additional Information section. 
0.5-0.7 
For example: 
Hematocrit 
.55-.75 
Hematocrit  50  60% 
>0.7 
or 
Hematocrit   ____% 
Bacterial monitoring 
5d shall be printed as part of the proper 
Monitoring 
name for pooled platelets. 
Bacterial test 
Indicate number of donors whose 
From X donors 
components are present in the pooled 
Donor Exposure 
product in the Additional Information 
(X= number of donors) 
section. 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org  US Consensus Standard, Version 3.0.0    81 
6.4  Core Conditions Text  
 
Table 8  Core Conditions Text 
 
 
Product      Print where 
Type  Blood Product  Print what  (all left justified, but see note on 
Page 65) 
Approx 450 mL plus 63 mL  Additional information line 1 
WB  Whole Blood, 450 mL  [anticoagulant]   
Store at 1 to 6 C  Additional information line 2 
Approx 500 mL plus 70 mL  Additional information line 1 
WB  Whole Blood, 500 mL  [anticoagulant]   
Store at 1 to 6 C  Additional information line 2 
From 450 mL [anticoagulant]  Additional information line 1 
RBC  Red Blood Cells, 450 mL  Whole Blood   
Store at 1 to 6 C  Additional information line 2 
From 500 mL [anticoagulant]  Additional information line 1 
RBC  Red Blood Cells, 500 mL  Whole Blood   
Store at 1 to 6 C  Additional information line 2 
ADENINE-SALINE (AS-1,  Attribute line 1 
AS-3, or AS-5) ADDED   
RBC  Red Blood Cells with additive, 450 mL  From 450 mL [anticoagulant]  Additional information line 1 
Whole Blood   
Store at 1 to 6 C  Additional information line 2 
ADENINE-SALINE (AS-1,  Attribute line 1 
AS-3, or AS-5) ADDED   
RBC  Red Blood Cells with additive, 500 mL  From 500 mL [anticoagulant]  Additional information line 1 
Whole Blood   
Store at 1 to 6 C  Additional information line 2 
Washed Red Blood Cells, 
  Note: No anticoagulant specified 
Rejuvenated Red Blood Cells, 
RBC           mL  Additional information line 1 
Deglycerolized Red Blood Cells, and 
Store at 1 to 6 C   Additional information line 2 
Deglycerolized Rejuvenated Red Blood Cells 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    82 
 
Product      Print where 
Type  Blood Product  Print what  (all left justified, but see note on 
Page 65) 
   Note: No anticoagulant specified 
Frozen Red Blood Cells and  
RBC          mL  Additional information line 1 
Frozen Rejuvenated Red Blood Cells 
Store at -65 C or colder  Additional information line 2 
           mL  Additional information line 1 
containing approx            mL  Additional information line 2 
RBC  Apheresis Red Blood Cells 
[anticoagulant]   
Store at 1 to 6 C  Additional information line 3 
ADENINE-SALINE (AS-1 or  Attribute line 1 
AS-3) ADDED   
           mL  Additional information line 1 
RBC  Apheresis Red Blood Cells with Additive 
containing approx            mL  Additional information line 2 
[anticoagulant]   
Store at 1 to 6 C  Additional information line 3 
Washed Apheresis Red Blood Cells, 
Deglycerolized Apheresis Red Blood Cells,  
____ mL  Additional information line 1 
RBC  Rejuvenated Apheresis Red Blood Cells, and 
Store at 1 to 6 C  Additional information line 2 
Deglycerolized Rejuvenated Apheresis Red 
Blood Cells 
Frozen Apheresis Red Blood Cells and 
____ mL   Additional information line 1 
RBC  Frozen Rejuvenated Apheresis Red Blood 
Store at -65 C or colder  Additional information line 2 
Cells 
Fresh Frozen Plasma 
         mL from [anticoagulant]  Additional information line 1 
Plasma, Frozen Within 24 Hours After 
PLASMA  Whole Blood   
Phlebotomy 
Store at -18 C or colder  Additional information line 2 
Plasma 
Thawed Fresh Frozen Plasma, if relabeled; 
Thawed Plasma, Frozen Within 24 hours            mL from [anticoagulant]  Additional information line 1 
PLASMA  After Phlebotomy, if relabeled;  Whole Blood   
Thawed Plasma, if relabeled;  Store at 1 to 6 C  Additional information line 2 
Liquid Plasma 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    83 
 
Product      Print where 
Type  Blood Product  Print what  (all left justified, but see note on 
Page 65) 
_____ mL   Additional information line 1 
Number of units in pool ____  Additional information line 2 
Pooled Fresh Frozen Plasma 
PLASMA  From [anticoagulant] Whole  Additional information line 3 
 
Blood   
Store at -18 C or colder  Additional information line 4 
Thawed Pooled Fresh Frozen Plasma,   _____ mL   Additional information line 1 
Thawed Pooled Plasma,  Number of units in pool ____  Additional information line 2 
PLASMA  Liquid Pooled Plasma, and  From [anticoagulant] Whole   
Liquid Pooled Recovered Plasma  Blood  Additional information line 3 
  Store at 1 to 6 C  Additional information line 4 
           mL  Additional information line 1 
containing approx            mL  Additional information line 2 
PLASMA  Apheresis Fresh Frozen Plasma 
[anticoagulant]   
Store at -18 C or colder  Additional information line 3 
           mL  Additional information line 1 
Thawed Apheresis Fresh Frozen Plasma,  
containing approx            mL  Additional information line 2 
PLASMA  Thawed Apheresis Plasma, and 
[anticoagulant]   
Liquid Apheresis Plasma 
Store at 1 to 6 C  Additional information line 3 
____ mL  Additional information line 1 
From [anticoagulant] Whole  Additional information line 2 
PLASMA  Recovered Plasma 
Blood   
[Storage Temperature]  Additional information line 3 
_____ mL  Additional information line 1 
Pooled Recovered Plasma and  Number of units in pool ____  Additional information line 2 
PLASMA  Liquid Pooled Recovered Plasma  From [anticoagulant] Whole   
  Blood  Additional information line 3 
[Storage temperature]  Additional information line 4 
_____ mL  Additional information line 1 
Containing approx ____ mL  Additional information line 2 
PLASMA  Source Plasma 
[anticoagulant]   
Store at -20 C or colder  Additional information line 3 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    84 
 
Product      Print where 
Type  Blood Product  Print what  (all left justified, but see note on 
Page 65) 
Approx 4070 mL  Additional information line 1 
From 450 mL [anticoagulant]  Additional information line 2 
PLT  Platelets, from 450 mL collection 
Whole Blood   
Store at 20 to 24 C   Additional information line 3 
Approx 4070 mL  Additional information line 1 
From 500 mL [anticoagulant]   
PLT  Platelets, from 500 mL collection 
Whole Blood  Additional information line 2 
Store at 20 to 24 C  Additional information line 3 
_____ mL  Additional information line 1 
PLT  Washed Platelets 
Store at 20 to 24 C  Additional information line 2 
           mL  Additional information line 1 
Number of units in pool ___  Additional information line 2 
PLT  Pooled Platelets   From [anticoagulant] Whole  Additional information line 3 
Blood    
Store at 20 to 24 C  Additional information line 4 
_____ mL  Additional information line 1 
PLT  Washed Pooled Platelets  Number of units in pool____  Additional information line 2 
Store at 20 to 24 C  Additional information line 3 
           mL  Additional information line 1 
containing approx            mL  Additional information line 2 
PLT  Apheresis Platelets 
[anticoagulant]   
Store at 20 to 24 C   Additional information line 3 
PAS - X Added (X=PAS  Attribute line 1 
solution)    
          mL   
Apheresis Platelets with Platelet Additive  containing approx            mL   
PLT 
Solution  [anticoagulant]  Additional information line 1 
Contains approx __%   
PAS/___% Plasma  Additional information line 2 
Store at 20 to 24 C   Additional information line 3 
______ mL  Additional information line 1 
PLT  Washed Apheresis Platelets 
Store at 20 to 24 C  Additional information line 2 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    85 
 
Product      Print where 
Type  Blood Product  Print what  (all left justified, but see note on 
Page 65) 
CRYO  Cryoprecipitated AHF  Store at -18 C or colder  Additional information line 1 
CRYO  Thawed Cryoprecipitated AHF, if relabeled  Store at room temperature  Additional information line 1 
           mL  Additional information line 1 
CRYO  Pooled Cryoprecipitated AHF  Number of units in pool ____   Additional information line 2 
Store at -18 C or colder  Additional information line 3 
 _____   mL  Additional information line 1 
Thawed Pooled Cryoprecipitated AHF, if 
CRYO  Number of units in pool ____     Additional information line 2 
relabeled 
Store at room temperature  Additional information line 3 
____ mL from [volume]  Additional information line 1 
WBC  Granulocytes  [anticoagulant] Whole Blood   
Store at room temperature  Additional information line 2 
Additional information line 1 
____ mL containing approx 
Additional information line 2 
____ mL (anticoagulant) in 
 
Hydroxyethyl Starch Solution 
 
WBC  Apheresis Granulocytes  (if HES is present; actual 
 
percentage of the HES may be 
 
included if desired) 
 
Store at room temperature 
Additional information line 3 
____ mL from [nominal  Additional information line 1 
WBC  Washed Granulocytes  volume] Whole Blood   
Store at room temperature  Additional information line 2 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    86 
 
Product      Print where 
Type  Blood Product  Print what  (all left justified, but see note on 
Page 65) 
Additional information line 1 
____ mL    
Number of units in pool ____  Additional information line 2 
From [anticoagulant] Whole   
Blood in ____ mL  Additional information line 3 
WBC  Pooled Granulocytes  Hydroxyethyl Starch Solution   
(if HES is present; actual   
percentage of the HES may be   
included if desired)   
Store at room temperature   
Additional information line 4 
____ mL containing approx  Additional information line 1 
____ mL (anticoagulant) in  Additional information line 2 
Hydroxyethyl Starch Solution   
(if HES is present; actual   
WBC  Apheresis Granulocytes-Platelets 
percentage of the HES may be   
included if desired)   
Store at room temperature   
Additional information line 3 
____ mL from [volume]  Additional information line 1 
WBC  Leukocytes  [anticoagulant] Whole Blood  Additional information line 2 
Store at [temperature] 
____ mL containing approx  Additional information line 1 
WBC  Apheresis Leukocytes  ____ mL [anticoagulant]   Additional information line 2 
Store at [temperature]  Additional information line 3 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    87 
 
Product      Print where 
Type  Blood Product  Print what  (all left justified, but see note on 
Page 65) 
For apheresis products:   
   
____ mL prepared by  Additional information line 1 
automated apheresis   
containing approx ____ mL  Additional information line 2 
[anticoagulant]    
WBC  Source Leukocytes  Store at [temperature]   Additional information line 3 
   
For Whole Blood products:   
   
____ mL from [volume]  Additional information line 1 
[anticoagulant] Whole Blood  Additional information line 2 
Store at [temperature]  Additional information line 3 
 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    88 
6.5  Coding and Labeling of Products for Further 
Manufacture 
 
ISBT 128 Attribute Codes on Figure 25 and Figure 26 refer to ISBT 128 Coding as defined 
in the Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions. 
While the table is reproduced here, consult this document, available on the ICCBBA 
website, for the latest information. 
 
Default: For  The product is intended for 
transfusion   transfusion. 
For mnf:  A product that is intended for injection 
injectable  into humans after further 
manufacturing (processing) 
For mnf:  A product that is intended for injection 
injectable restr  into humans after further 
use  manufacturing (processing). The use 
of the product is further restricted by 
national regulation or guidelines 
For mnf:  A product that is intended for further 
noninjectable  manufacturing into a product that is 
not intended for injection into humans 
For mnf:  A product that is intended for further 
noninjectable  manufacturing into a product that is 
restr use  not intended for injection into 
humans. The use of the product is 
further restricted by national 
regulation or guidelines  
Not for tx or  A product that is not to be used for 
mnf  transfusion/transplantation or further 
manufacturing into products for 
human use 
 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
    US Consensus Standard, Version 3.0.0    89 
 
Figure 25  Coding & Labeling of Products for Further Manufacture  Research and Injectable 
 
 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    90 
 
Figure 26  Coding & Labeling of Products for Further Manufacture  Noninjectable 
 
 
 2013  ICCBBA   All rights reserved  www.iccbba.org 
  US Consensus Standard, Version 3.0.0    91 
6.6  Donation Type in Product Description Code 
 
Table 9  Donation Type Text (Sixth Position in the Product Code Data Structure) 
 
 
Upper Left 
 
    Quadrant 
  Upper Right 
Sixth Data  Type of  [in no less 
Lower Left Quadrant  Quadrant 
Character  Donation  prominence 
 
than Component 
Class] 
 
 
  Voluntary  VOLUNTEER   
V  allogeneic   
DONOR1   
donation 
0  Not specified1       
Data content text   FOR 
Voluntary 
VOLUNTEER  beneath bar code:  LABORATORY 
R  research 
DONOR  RESEARCH  RESEARCH USE 
donation 
  ONLY 
   
 
  Voluntary  Data content text   
VOLUNTEER 
S  source  beneath bar code:   
DONOR1 
donation  SOURCE 
 
The disease of the 
patient from which the 
 
  unit was collected   
  Voluntary  VOLUNTEER  must be specified. 2  THERAPEUTIC 
T  therapeutic 
DONOR  Data content text  COLLECTION 
collection2 
beneath bar code: 
THERAPEUTIC 
 
Paid 
       
P  allogeneic  PAID DONOR     
collection 
Data content text  FOR 
 
  Paid research    beneath bar code:  LABORATORY 
r  PAID DONOR 
collection  RESEARCH  RESEARCH USE 
  ONLY  
Data content text 
 
  Paid source    beneath bar code: 
s  PAID DONOR1   
collection  SOURCE 
 
Autologous 
Data content text 
collection,  VOLUNTEER  AUTOLOGOUS 
A  beneath bar code: 
eligible for  DONOR  DONOR 
AUTOLOGOUS 
crossover3 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    92 
 
Upper Left 
 
    Quadrant 
  Upper Right 
Sixth Data  Type of  [in no less 
Lower Left Quadrant  Quadrant 
Character  Donation  prominence 
 
than Component 
Class] 
X  Data content text  BIOHAZARD 
For autologous 
VOLUNTEER  beneath bar code:  FOR 
use only, 
DONOR  AUTOLOGOUS  AUTOLOGOUS 
biohazard 
  USE ONLY  
Volunteer 
  Data content text 
directed 
VOLUNTEER  beneath bar code:   
D  collection,  DONOR  DIRECTED   
eligible for   
 
crossover 
Paid directed  Data content text  FOR 
collection,  beneath bar code:  DESIGNATED 
d  PAID DONOR 
eligible for  DIRECTED  RECIPIENT 
crossover    ONLY4 
Data content text 
FOR 
For autologous  VOLUNTEER  beneath bar code: 
1 (one)  AUTOLOGOUS 
use only  DONOR  AUTOLOGOUS 
USE ONLY 
 
Data content text  FOR 
For directed 
VOLUNTEER  beneath bar code:  DESIGNATED 
2  recipient use 
DONOR  DIRECTED  RECIPIENT 
only 
  ONLY 
BIOHAZARD 
For directed  Data content text 
FOR 
recipient use  VOLUNTEER  beneath bar code: 
3  DESIGNATED 
only,  DONOR  DIRECTED 
RECIPIENT 
biohazard   
ONLY 
Data content text  FOR 
Designated  VOLUNTEER  beneath bar code:  DESIGNATED 
4 
collection  DONOR  DESIGNATED  RECIPIENT 
  ONLY4 
Data content text  FOR 
Dedicated  VOLUNTEER  beneath bar code:  DESIGNATED 
5  
donation  DONOR  DEDICATED  RECIPIENT 
  ONLY4 
 
1 For Source Plasma, printing VOLUNTEER DONOR or PAID DONOR on the label is optional in 
the US. Donation type may be listed as Non-specified since indicating VOLUNTEER DONOR 
or PAID DONOR is not required. 
 
2  Facilities may eliminate the donor's disease from the label if the facility has been granted 
approval from FDA for an alternative procedure to 21 CFR 640.3(d) under the provisions of 21 
 
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  US Consensus Standard, Version 3.0.0    93 
CFR 640.120 to distribute Whole Blood and blood components collected from individuals with 
diagnosed hereditary hemochromatosis (HH) without indicating the donors disorder on the 
container label. In this situation encoding the V rather than T in the Donation Type is 
appropriate. 
 
3 Shaded line indicates a type of donation (autologous eligible for crossover) that is not commonly 
used in the US. It is included for the sake of completeness since it is not precluded by federal 
regulations. Software in the US is unlikely to support this option. 
 
4 If the donation may be crossed over, For Designated Recipient Only need not appear in the 
upper right quadrant. 
 
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  US Consensus Standard, Version 3.0.0    94 
7 Illustrations of US Labels 
                                                                                                                                                             
 
Logos 
 
The ISBT 128 Standard Technical Specification 
makes no provision for logos. Facilities may place a 
logo in the upper left or lower right quadrant should 
they choose, provided it does not interfere with any 
other required item. 
 
7.1  Introduction 
 
The examples given in this section are illustrations, not copies of actual labels. Together 
these illustrations demonstrate facets of labeling under ISBT 128 appropriate for the US. 
They are not meant to be an exhaustive compilation of all possible arrangements nor all 
possible blood products. From these illustrations, and applying the principles and rules 
described in Chapters 5 and 6, it should be possible to design any label not illustrated in 
this chapter. 
 
Typefaces and sizes used in these illustrations are constrained by the software used to 
produce them. Given this constraint, the illustrations are internally consistent and conform 
to the rules and logic as written. The actual appearance of any professionally-produced 
label may be more pleasing to the eye, and the typeface used may provide letters and 
numbers of a larger height than shown in these illustrations. All facilities should work with 
their chosen vendor(s) to achieve labeling that meets with FDA approval, is consistent 
with this document, and presents the required information in the best way possible 
concomitant with the goal of transfusion recipient safety. 
 
7.2  Container Manufacturers Base Label 
 
All primary containers used in the US for whole blood and apheresis collections and 
storage should be labeled with a base label with wording approved by the FDA. The 
placement of two bar codes on the base label should comply with the ISBT 128 Standard 
Technical Specification. The first of these bar codes represents the identity of the 
manufacturer, the catalog number, and the identification of the container within the set. 
The second bar code is the lot number of the container set. 
 
   
 
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  US Consensus Standard, Version 3.0.0    95 
7.2.1  Container Manufacturer and Catalog Number 
 
The interpretation of the container set information, encoded as a catalog number in 
the last seven data characters of the first bar code, will be provided in literature 
supplied by the container manufacturer.  
7.2.1.1  Manufacturers Data File 
 
This information may also be linked to a data file that contains a great deal 
of information about the collection set as well as information about specific 
containers within the collection set. With appropriate software, the catalog 
number bar code on a blood container can be scanned during use and 
linked to the data file to obtain or document a complete description of the 
set and containers. For example, by scanning the bar code on a whole 
blood collection set and linking it to the data file, the user can document the 
set manufacturer, the intended collection volume (e.g., 450 mL), the 
anticoagulant and its volume, and the number and type of attached 
containers.  
 
The information in this data file is not intended as a specification of a 
container or a container set, but solely to provide process control 
information for use in blood collection management systems. Details of this 
very powerful tool for process control are found in the ISBT 128 Standard 
Technical Specification and Implementation Guide: Use of the 
Manufacturers Data File. 
 
 
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  US Consensus Standard, Version 3.0.0    96 
 
7.2.2    Base Label Illustrations 
 
Figure 27  100 mm by 106 mm (4" x 4.25") Base label 
 
       
                         
                          
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This example represents the minimum amount of ISBT 128 information that must 
appear on the label. Manufacturers may include additional information such as: 
 
  user friendly catalog numbers and lot numbers 
  the intended use of the bag in text (e.g., For Platelet Storage) 
  appropriate warnings (e.g., Not Suitable for Storage of Red Blood Cells 
or the number of days a platelet product can be stored within the 
container) 
 
                      
 
 
 
 
 
 
 
 
 
 
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  US Consensus Standard, Version 3.0.0    97 
 
 
Figure 28  Base Label for Small Container 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This example represents the minimum amount of ISBT 128 information that must 
appear on the label. Manufacturers may include additional information such as: 
 
  user friendly catalog numbers and lot numbers 
  the intended use of the bag in text (e.g., For Platelet Storage) 
  appropriate warnings (e.g., Not Suitable for Storage of Red Blood Cells 
or the number of days a platelet product can be stored within the 
container) 
 
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  US Consensus Standard, Version 3.0.0    98 
7.3  Final Primary Container Label Illustrations 
 
Figure 29  Primary ContainerRed Blood Cells 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Primary ContainerRED BLOOD CELLSUS license number in Lower Left Quadrant 
 
Note: The 6.4 mm [14"] Section projecting below the 100 mm [4"] wide by 100 mm [4"] long primary 
container label is the visible portion of the base label applied to the empty container by the 
manufacturer of the container set. 
 
 
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  US Consensus Standard, Version 3.0.0    99 
7.4  Final Satellite Container Label Illustrations 
 
 Figure 30  Satellite Container--Platelets 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  US Consensus Standard, Version 3.0.0    100 
 
Figure 31  Satellite ContainerPLATELETSUS License Number in Upper Left Quadrant 
 
 
 
 
 
 
 
 
 
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7.5  Upper Right Quadrant   
 
Figure 32  Rh Positive Label 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 33  Rh Negative Label 
 
 
     
 
                         
                                      
 
 
               
 
 
         
                                             
 
Figure 34  Rh Not Specified Label
 
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  US Consensus Standard, Version 3.0.0    102 
 
Figure 35  Autologous Products for Upper Right Quadrant 
 
 
                                  
 
 
Figure 36  Directed, Designated and Dedicated Labels for Upper Right Quadrant 
 
                                                        
 
 
 
 
 
 
 
 
 
 
 
 
 
Note that (n-2) and (n-4) from Table 3, page 37, are used in the ABO/Rh Blood Groups bar code 
for all directed, designated, and dedicated donations that are intended for a specific recipient only. 
If the product may be crossed over, the differentiation between directed, designated, and 
dedicated may be made in the Product Code Data Structure (see 4.3.1.4, page 43). 
 
Containers labeled as above should also bear an Intended Recipient Information label either 
affixed to the product or as a tie tag. 
 
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Figure 37  ABO/Rh for Emergency Release 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: When blood is released from the collection facility before testing is completed, another label 
or tie tag should indicate which tests have and have not been performed.   
 
Figure 38  Bombay and Para-Bombay Phenotypes 
 
 
 
                                                
 
 
 
 
 
 
 
 
 
 
Figure 39  Therapeutic Collection Upper Right Quadrant 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  US Consensus Standard, Version 3.0.0    104 
 
7.6  Lower Left Quadrant Labels  
 
   
Figure 40  Whole Blood Figure 41  Whole Blood, Low Volume
Figure 42  Red Blood Cells  Figure 43  Red Blood Cells with Additive 
 
 
 
 
 
 
 
 
 
Figure 44  Divided RBCs  Figure 45  Irradiated RBCs 
   
   
 
 
 
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  US Consensus Standard, Version 3.0.0    105 
Lower Left Quadrant Labels (continued)  
Figure 46  Leukocytes Reduced RBCs   Figure 47  Washed, Leukocytes Reduced 
RBCs 
 
 
   
Figure 48  Irradiated, Leukocytes Reduced  Figure 49  Deglycerolized RBCs 
RBCs 
 
 
   
   
   
Figure 50  Divided, Irradiated, Leukocytes  Figure 51  Red Blood Cells, Low Volume 
Reduced Apheresis RBCs   
 
 
 
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  US Consensus Standard, Version 3.0.0    106 
Lower Left Quadrant Labels (continued)  
 
Figure 52  Platelets  Figure 53  Pooled Platelets 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
Figure 55  Apheresis Platelets 
Figure 54  Pooled Platelets -5d 
 
   
Figure 56  Low Yield Apheresis Platelets  Figure 57  Apheresis Platelets with PAS 
   
 
 
 
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  US Consensus Standard, Version 3.0.0    107 
Lower Left Quadrant Labels (continued)  
 
Figure 58  Apheresis Plasma with 24 Hour  Figure 59  Apheresis FFP  
Room Temperature Hold 
 
Figure 60  Plasma Frozen <24 Hours after  Figure 61  Fresh Frozen Plasma 
Phlebotomy 
 
   
 
Figure 62  Thawed Fresh Frozen Plasma 
 
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  US Consensus Standard, Version 3.0.0    108 
  Lower Left Quadrant Labels (continued)  
                       
Figure 63  Cryoprecipitated AHF  Figure 64  Pooled Cryoprecipitated AHF 
 
 
 
Figure 65  Thawed Pooled Cryoprecipitated   
AHF  
 
                                                            
      
 
 
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  US Consensus Standard, Version 3.0.0    109 
 
7.7  Special Testing Labels 
 
Figure 66  Special Testing General and Red Cell Antigen Labels 
             
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
To save space, it is permissible to print only negative antigens and omit punctuation between red 
cell antigens. Abbreviations such as Anti-CMV Neg. and Hgb S Neg. are acceptable, as are more 
complete phrases such as Negative for Antibodies to CMV or Hemoglobin S Negative. 
 
 
Figure 67  Red Cell Antigen Label  Negative Antigens Only 
 
 
 
 
 
 
 
 
 
 
 
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  US Consensus Standard, Version 3.0.0    110 
 
Figure 68  Full Label with Red Cell Phenotype 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
 
If more than one bar code appears in the lower right quadrant, the height of the bar code may 
need to be reduced as shown in Figure 68. The height should be at least 15% of the length of the 
bar code. 
 
When a full phenotype is printed, it is acceptable to abbreviate information about the CMV and 
Hemoglobin S status, as well as FDA Registration Number and US License text, as shown in 
Figure 68. 
 
A subcommittee of the Americas Technical Advisory Group is working on consensus for the order 
and format in which antigens will appear in text on the label. 
 
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  US Consensus Standard, Version 3.0.0    111 
7.8  Autologous Label 
 
Figure 69  For Autologous Use Only Label 
 
 
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  US Consensus Standard, Version 3.0.0    112 
 
7.9  Labeling Specific Products 
 
There may be multiple ways to encode a given product which vary by the amount of detail 
provided. For example, frozen cells may be encoded with the concentration of glycerol or 
without it. In the interest of standardization, a working group of the Americas Technical 
Advisory Group (ATAG) determined the preferred coding for the US. Their decisions are 
captured in this chapter. 
 
In some cases, products are included in this section because they do not follow the 
General Rules outlined in 6.1, beginning on page 63. 
 
The following sections provide guidance on selection of Product Description Codes and 
labeling of specific products within the US. As noted in the Preface, bar code text is the 
prerogative of a country, and the instructions that follow are US-specific. 
7.9.1  Pooled Blood Products 
 
These products shall be given a new Donation Identification Number (DIN) and not 
use a DIN from one of the units in the pool. The new DIN shall have the Facility 
Identification Number of the pooling facility. 
 
The DINs and the ABO/Rh of the units that make up the pool shall be in the records 
kept by the facility that prepares the pool; they are not required to be on the label 
but may appear on a tie tag. The actual volume and the number of units in the pool 
shall appear on the affixed label, as illustrated in Figure 70 and Figure 73, page 
114.  
 
The use of an Attribute which defines the number of units in the pool is acceptable, 
but not required. This may be used when the facility routinely varies the number of 
units within a pool. If a facility routinely uses the same number of units (e.g., has a 
standardized pool of 5 units for platelets), then encoding the information might not 
be helpful and Product Description Codes without Attributes for the number of 
donors may be used. 
 
If Pooled Platelets contain a mixture of Rh positive and Rh negative products, they 
may either be labeled Pooled Rh or Rh positive.  
 
The label of Pooled Cryoprecipitated AHF does not need to indicate Rh. 
 
If pooled platelets contain mixed anticoagulants, the product should be coded as 
POOLED PLATELETS|NS/XX/20-24 C, (see Use of Product Code Data Structure 
[003]  Blood for explanation on coding). The NS in the first position of the core 
conditions indicates that the anticoagulant is not specified in the machine readable 
information, but it shall appear in text on the label. The XX indicates the nominal 
collection volume is not encoded. Actual volume shall appear on the label. See 
 
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  US Consensus Standard, Version 3.0.0    113 
Figure 73, page 114. Platelet pools with mixed anticoagulants should have 4 hour 
dating.  
 
Figure 70  Pooled Platelets, Mixed Anticoagulant 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 71  Thawed Pooled Cryoprecipitated AHF, Rh Not Specified 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  US Consensus Standard, Version 3.0.0    114 
 
Figure 72  Thawed Pooled Cryoprecipitated AHF, Group A, Rh Pooled  
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 73  Pooled Platelets 
 
 
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  US Consensus Standard, Version 3.0.0    115 
7.9.2  Reconstituted Red Blood Cells 
 
Reconstituted Red Blood Cells refer to red cells to which plasma is added, often to 
a specific hematocrit.  
 
7.9.2.1  Selecting a Product Description Code 
 
Depending on the way in which they are made, they are encoded as 
follows:
 
IF  THEN 
The product is made by adding  Product is encoded as Red Blood 
blood group-compatible plasma  Cells with the Attribute Plasma 
to red blood cells  Added 
The product is made by first  Product is encoded as Red Blood 
removing additive from the red  Cells with the Attribute 
blood cells and then adding  Supernatant removed/Plasma 
blood group-compatible plasma  added 
The product is made by removing  Product is encoded as Red Blood 
some of the plasma from red  Cells with the Attribute Plasma 
blood cells and then adding  reduced/Plasma added 
blood group-compatible plasma   
 
7.9.2.2  Donation Identification Number 
 
Some computer systems treat reconstituted red cells as a pooled product; 
others do not. The Donation Identification Number (DIN) can either be a 
newly assigned Pool Number (for those systems that treat the product as a 
pooled product) or that of the red blood cells (for those systems that do not 
treat it as a pooled product). The text name and location of the facility that 
appears beneath the DIN shall correspond to the Facility Identification 
Number within the DIN. That means, if the original DIN of the red blood 
cells is used, the name beneath the DIN shall correspond to the collection 
facility. If a new pool number is assigned to the product, the DIN shall have 
the Facility Identification Number of the pooling facility, and the name 
beneath the DIN shall be that of the pooling facility. Regardless of which 
method is chosen, traceability of both the red blood cells and the plasma 
shall be assured. The DIN of the plasma must be associated with the DIN 
of the final product in the facility records. See Figure 74 and Figure 75. 
 
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  US Consensus Standard, Version 3.0.0    116 
Figure 74  Reconstituted Red Cells, Pool Number Assigned 
 
 
 
FIN A9999 
 
corresponds to 
 
St. Marys 
Hospital   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 75  Reconstituted Red Blood Cells, Original RBC DIN Retained 
 
 
FIN W0000     
corresponds to  
Accurate    
Blood Center  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: The name of the modifying facility in the lower right quadrant is required ONLY if the product 
leaves the modifying facility. 
 
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  US Consensus Standard, Version 3.0.0    117 
7.9.2.3  ABO/Rh, anticoagulant and volume 
 
The ABO/Rh, anticoagulant, and volume of both the red blood cells and the 
plasma must be on the label.  
 
7.9.2.4  Number of donors 
 
The US has chosen not to use an Attribute indicating the number of donors 
in this product. 
 
7.9.2.5  Hematocrit 
 
Hematocrit may optionally appear on the label. 
 
7.9.2.6  Modifiers 
 
The proper name of this product is Reconstituted Red Blood Cells. If 
Modifiers apply, they should be printed before Reconstituted Red Blood 
Cells. That is, if the red blood cells were washed, the name of the product 
becomes Washed Reconstituted Red Blood Cells.  
 
7.9.2.7  Additional processing 
 
If the red cell, but not the plasma, component is irradiated and/or leukocyte 
reduced, labeling and Product Description Code selection becomes more 
complicated.  
 
Please see the US Frequently Asked Questions on the ICCBBA Website or 
contact the ICCBBA office (iccbba@iccbba.org) for current thinking on how 
these products should be labeled. 
 
7.9.2.8  CMV 
 
If the red cell, but not the plasma, component is tested and found negative 
for antibodies to CMV, labeling becomes more complicated.  
 
Please see the US Frequently Asked Questions on the ICCBBA Website or 
contact the ICCBBA office (iccbba@iccbba.org) for current thinking on how 
these products should be labeled. 
 
 
 
 
 
 
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  US Consensus Standard, Version 3.0.0    118 
7.9.3  Divided Products 
 
If the seventh and eighth data characters are other than 00, then the term 
DIVIDED shall appear on the label in the first Attribute line, followed by Attributes 
such as LEUKOCYTES REDUCED. A notation describing the division number 
may appear in the text below the storage temperature, but this is not required.  
 
Figure 76  Divided Product 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  US Consensus Standard, Version 3.0.0    119 
 
Examples of Use of Division Codes for Pediatric Aliquots 
Section 4.3.1.5 discussed how divisions of blood products are labeled. To further clarify 
this for pediatric divisions, the following two examples are provided. 
Example 1: Pediatric Aliquots 
An undivided 200-mL unit of AS-1 Red Blood Cells is the starting product.  
  A 50-mL aliquot is removed from this unit. In fact, this can be viewed as dividing the 
unit into two subunits that are denoted as A0 and B0.  
  One of these subunits (A0) has 150 mL and becomes a parent unit and is 
returned to storage. It is important that this parent unit be labeled A0 to indicate it 
is no longer a full unit. The other (B0) aliquot has 50 mL and is transfused.  
  Later, a 50-mL aliquot is removed from A0. This aliquot is labeled Aa. The parent 
unit, A0, remains labeled A0.  
  A few hours later, a 25-mL aliquot is removed from A0. This aliquot is labeled Ab. 
A0 remains A0. 
  Later yet, another 25-mL aliquot is removed from A0. This aliquot is labeled Ac. A0 
remains A0. 
  A0 eventually expires and is discarded. 
 
In the original division, it does not matter which part (A0 or B0) becomes the parent unit. 
However, traceability must be maintained. Therefore, any aliquots taken from A0 must be 
labeled Aa, Ab, Ac, etc. Any aliquots taken from B0 must be labeled Ba, Bb, Bc, etc. 
It would be good practice for a facility to determine how it will label its aliquots (i.e., 
whether the parent unit is A0 or B0) and be consistent about this approach. 
 
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  US Consensus Standard, Version 3.0.0    120 
Example 2: Pediatric Aliquots 
An alternative to Example 1 is labeling all aliquots as children of the parent unit.  
The starting product is a 200-mL unit of red cells. 
  A 50-mL aliquot is removed from a 200-mL unit. Immediately, the label on the 
primary pack is changed to A0 division indicating it is no longer a full unit. The first 
aliquot is labeled Aa. 
  Later a 50-mL aliquot is removed from A0. It is labeled Ab. The parent unit remains 
A0. 
  Later a 25-mL aliquot is removed and it is labeled Ac. The parent unit remains A0. 
  Later another 25-mL aliquot is removed and it is labeled Ad. The parent unit 
remains A0. 
  A0 eventually expires and is discarded. 
 
 
 
 
 
 
 
The ISBT 128 system is flexible to allow users to adapt a system that suits them as long as 
each aliquot is traceable (i.e., there must never be two aliquots labeled Aa). 
7.9.4  Frozen Red Blood Cells 
 
The ISBT 128 Standard allows encoding of Frozen Red Blood Cells to include the 
glycerol concentration or not. The US has chosen not to encode the glycerol 
concentration since it is not required. 
 
Neither the anticoagulant nor the nominal collection volume needs to appear on 
the label. The actual volume shall appear on the label. 
 
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  US Consensus Standard, Version 3.0.0    121 
7.9.5  Washed, Deglycerolized, or Rejuvenated Red Blood 
Cells 
 
Neither the anticoagulant nor the nominal collection volume needs to appear on 
the label. The actual volume shall appear on the label. 
7.9.6  Granulocytes - Untested 
 
Granulocyte products may be released from the collection center prior to 
completion of testing because of their short shelf life. The upper right quadrant in 
this case should indicate the product is being released for emergency use only and 
include the name of the patient. The name of the hospital on the affixed label is 
optional, but should be included in the labeling of the product (e.g., tie tag). As 
described in 5.1.3.4, page 59, if the blood has not been tested for the required 
infectious disease markers either: 
 
(1) the results of tests for infectious disease markers that have been performed 
and indication of which tests have not been completed shall appear on the 
affixed label in the lower right quadrant or  
 
(2) this information shall appear on a tie tag and a phrase such as SEE TIE TAG 
FOR TEST RESULT INFORMATION should appear in this quadrant. (See 
Figure 101, Page 144 for an example tie tag.)    
 
Similarly, the message DONOR TESTED WITHIN THE LAST 30 DAYS should 
appear in this quadrant, when appropriate. 
 
The percentage of HES on the label (e.g., 6% Hydroxyethyl Starch Solution) is 
optional. The label may simply state, ____ mL Hydroxyethyl Starch Solution.  
 
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  US Consensus Standard, Version 3.0.0    122 
 
Figure 77  Granulocytes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.9.7  Plasma Products 
 
The nominal collection volume does not need to appear on the label. The actual 
volume shall appear on the label. 
7.9.8  Thawed Plasma Products or Cryoprecipitated AHF 
 
Thawed Plasma products (used within their 6-24 hour dating period) and Thawed 
Cryoprecipitated AHF (used within its 6 hour dating period for a single unit) may 
retain their original Product Description Codes (frozen code) or be changed to a 
Product Description Code indicating they have been thawed. That is, either a code 
for Fresh Frozen Plasma or a code for Thawed Fresh Frozen Plasma may be used. 
Only the expiration date/time must be changed and this information does not have 
to be bar coded. 
 
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  US Consensus Standard, Version 3.0.0    123 
 
Figure 78  Thawed Plasma with Manually Changed Expiration 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
If Fresh Frozen Plasma and Plasma that has been frozen within 24 hours after 
phlebotomy (made in a closed system) are not used within the allowable 6- or 
24-hour periods following thawing, they shall be relabeled as Thawed Plasma. 
This requires applying a new product label that is both machine and eye-readable. 
This product is not a licensable product and the US License Number shall not 
appear. 
 
Figure 79  Thawed Plasma 
 
 
 
 
 
 
 
 
 
 
No US License 
Number 
 
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  US Consensus Standard, Version 3.0.0    124 
 
7.9.9  Apheresis Fresh Frozen Plasma 
 
In the US Apheresis Fresh Frozen Plasma (FFP) that is collected into a single bag 
and subsequently divided into smaller ADULT aliquots (e.g., 600 mL is collected 
and divided into three 200-mL aliquots) may be given either container 
designations (different Product Description Codes) as shown in Figure 80 and 
Figure 81 or division codes (7th and 8th character designations) as shown in 
Figure 82.  
 
If the plasma is divided into aliquots smaller than a standard adult dose (as defined 
by the facility), it must be given division codes (7th and 8th character designations).  
 
 
Figure 80  Apheresis FFP with 1st Container Designation (Product Code E4689V00) 
 
 
 
 
Product Code for 
1st C ontainer is 
 
E4689V00 
 
 
 
 
 
 
Text indicating 
contain er number 
 
 
Figure 81  Apheresis FFP with 2nd Container Designation (Product Code E4693V00) 
Product Code 
for 2nd Container 
is E4693V00 
Text indicating 
container number 
 
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  US Consensus Standard, Version 3.0.0    125 
 
Figure 82  Apheresis FFP with Division Code 
 
 
 
 
Product Code is 
 
E0869VA0 (the 
 
A0 represents 
 
a division) 
 
 
 
 
 
Text indicating 
divisio n number 
 
 
Further Divisions 
 
It is possible that these products could be further divided for pediatric use. Should 
products using the Container codes be further divided, the Division Codes 
(Position 7 and 8 of the Product Code) would be used. That is, Divisions of 
E4693V00 from the above example would become E4693VA0 and E4693VB0, etc. 
See Figure 83. 
 
Figure 83  Product with Container Number Further Divided 
 
. 
Product Code is 
 
E4693VA0 (the 
  A0 represents 
  a division) 
 
 
 
 
 
Text indicating 
  container and 
  division number 
 
 
If products using the division codes are further divided, the 8th position of the 
Product Code is used. That is, from the above example, divisions of E0869VA0 
become E0869VAa, E0869VAb, etc. See Figure 84. 
 
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  US Consensus Standard, Version 3.0.0    126 
 
Figure 84  Divided Product Further Divided 
 
 
  Product Code is 
E0869VAa (the 
 
Aa represents 
 
a division and 
 
subdivision) 
 
 
 
 
 
Text indicating 
 
division and 
  subdivision 
  number 
 
 
Apheresis Fresh Frozen Plasma (FFP) may be made in either an open system or a 
closed system. If it is made in an open system, the dating on the thawed plasma 
may not be extended beyond the original 6- or 24-hour period. The label text must 
indicate the plasma was made in an open system. 
 
Figure 85  Apheresis Fresh Frozen Plasma, Open System 
 
 
 
 
 
 
 
 
 
 
 
 
7.9.10  Thawed Apheresis Fresh Frozen Plasma 
 
A thawed Apheresis Fresh Frozen Plasma product (used within its 6-24 hour 
dating period) may retain its original Product Description Code (frozen code) or 
be changed to a Product Description Code indicating it has been thawed. That is, 
either a code for Apheresis Fresh Frozen Plasma or for Thawed Apheresis Fresh 
Frozen Plasma may be used. Only the expiration date/time must be changed and 
this information does not have to be bar coded. 
 
 
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  US Consensus Standard, Version 3.0.0    127 
If Thawed Apheresis Fresh Frozen Plasma is not used within the allowable 6- or 
24-hour periods following thawing, and it was made in a closed system, it may be 
relabeled as Thawed Apheresis Plasma. This requires applying a new product 
label that is both machine and eye-readable. This is not an FDA licensable product 
and an FDA License Number shall not appear on the label. 
7.9.11  Apheresis Red Blood Cells 
 
When multiple adult doses of Apheresis Red Blood Cells are collected, Product 
Description Codes with container Attributes (e.g., 1st container or 2nd container) 
shall be selected. If only one red cell product is collected, a Product Description 
Code with no container Attributes should be selected. 
 
Below the storage temperature, the Container designation may be printed, but this 
is not required. 
7.9.12  Pooled Platelets with Bacterial Monitoring or Bacterial 
Test 
 
Pooled platelets which have had bacterial testing or monitoring AND meet the 
criteria in the US for extension of dating should be labeled as Pooled Platelets -5d. 
Only platelet products that have their expiration extended because of bacterial 
testing may use the Attributes Bacterial Monitoring or Bacterial Test. (See 
definitions of these Attributes in Standard Terminology for Blood, Cellular Therapy, 
and Tissue Product Descriptions). 
 
Further modification (e.g., washing or reducing the plasma volume) of this product 
such that the dating is no longer extended causes the product to lose the bacterial 
monitoring or bacterial test Attribute. 
 
Figure 86  Pooled Platelets with Bacterial Monitoring or Bacterial Test 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    128 
7.9.13  Apheresis Platelets   
 
Users must understand the terms and definitions in the Glossary under Apheresis 
Platelet Terminology to understand this section. 
 
Container Designation or Division Code Text: Below the storage temperature, 
the Container designation shall be printed. The Division code may also be printed 
in this space. See Figure 87 for an example of Container Code designation. 
 
Figure 87  Container Code on Apheresis Platelets 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Single Collection and Divided Products with <3 x 1011 Platelets: Single 
collections and divided products with platelet yields <3 x 1011 are considered low 
yield. Product description codes for these platelets should include the Attribute 
<3E11 plts from the Dosage  Additional Information attribute group. The actual 
platelet yield on these units shall appear on the label. See Figure 88. 
 
Figure 88  Example Statement on Low Yield Collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  US Consensus Standard, Version 3.0.0    129 
Single, Double or Triple Collections and Divided Products with 3 x 1011 
Platelets: Optionally, a facility may elect to include the platelet yield on a product 
with 3 x 1011 platelets. See Figure 89. A Product Description Code with the default 
Dosage: No additional Information from the Dosage  Additional Information 
attribute group should be selected.  
 
Figure 89  Example of Optional Platelet Yield Statement 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    130 
 
Selection of Product Description Codes: 
Users are reminded to review terms and definitions for Apheresis Platelet 
Terminology in the Glossary to interpret this chart. 
 
IF  Then 
Single Collection  Product Description Codes without container 
Attributes should be selected (e.g., E3077 Apheresis 
PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6) 
Low Yield Single  Product Description Codes without container 
Collection  Attributes and with Attribute <3E11 plts should be 
selected (e.g., E4643 Apheresis 
PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|<3E11 
plts) 
Products from a Double  Product Description Codes with container Attributes 
or Triple Collection  should be selected (e.g., codes with 1st container or 
2nd container such as E3087 Apheresis 
PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|1st 
container). See Figure 87. 
Divided Product  Division codes (codes such as A0 and B0 in the 7th 
and 8th position of the Product Code) should be used. 
See Figure 90, Figure 91, and Example of Product 
Description Code Selection in text box below. 
Low Yield Divided  Product Description Codes with Attribute <3E11 plts 
Product  should be selected. Division codes (codes such as A0 
and B0 in the 7th and 8th position of the Product Code) 
should be used. See Figure 91 and Example of 
Product Description Code Selection in text box below. 
Single Platelet Collection  Product Description Codes without container 
with Red Cells or Plasma  Attributes should be selected (e.g., E3077 Apheresis 
Co-components  PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6) 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    131 
 
 
Ex ample of Product Description Code Selection: 
 
 
  Beginning product (Single Collection, platelet yield = 5.8 x 1011):  E3077V00 
 
  (Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6), undivided 
 
Th is product is divided into two portions, one of which has a platelet yield of 2.7 x 
10 11 platelets and the other has a platelet yield of 3.1 X 1011 platelets. These 
pr oducts should be labeled as: 
 
   Product with 2.7 x 1011 platelets:  E4643VB0 (Apheresis 
 
PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|<3E11 plts), divided (See Figure 
 
90). 
 
   
    Product with 3.1 X 1011 platelets:  E3077VA0 (Apheresis 
 
PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6), divided (See Figure 91). 
   
 
It does not matter which product becomes A0 and which becomes B0. However, it is 
 
recommended that facilities develop a policy for which division code is assigned to 
 
the standard product and which is assigned to the low yield product, and then be 
 
consistent in following their policy. 
 
 
 
 
Additional examples may be found in the FAQ section of the ICCBBA website. 
There are a few exceptions to the above rules. Users are advised to consult their 
FDA Consumer Safety Officer for more details. 
 
 
   
Figure 90  Divided Low Yield Product  
 
 
 
 
 
 
 
 
 
. 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    132 
 
Figure 91  Divided Product (Yield 3 x 1011)  
 
 
 
 
 
 
 
 
   
 
 
Figure 92  Divided Product from Second Container 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  US Consensus Standard, Version 3.0.0    133 
7.9.14  Recovered Plasma 
 
Recovered Plasma shall be coded as Plasma with an Intended Use Attribute 
indicating it is intended for manufacture. A collection date shall appear on the label. 
Donation type may be 0 (zero) (indicating the donation type is not specified) or V (if 
donor was a volunteer donor). Test results should display in the lower right 
quadrant.  
 
Figure 93  Recovered Plasma 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Specific text associated with Recovered Plasma may be found on Figure 25, page 
89 and Figure 26, page 90. At the bottom of the chart are the ISBT 128 Product 
Description Code Attributes associated with each type of Recovered Plasma. 
Attributes with the phrase restr use (restricted use) shall be used for Recovered 
Plasma that is to be manufactured into a product that is not FDA licensed.  
 
 
 
 
 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    134 
 
Figure 94  Additional Recovered Plasma Label Examples Showing Lower Quadrants 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: These examples show only the lower half of the label. The upper portion of the label should 
appear as shown in Figure 93.
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    135 
 
7.9.15  Source Plasma 
 
Source Plasma is to be coded as Apheresis Plasma with an Intended Use Attribute 
indicating it is intended for manufacture. The expiration date must appear on the 
label. In some cases, a collection date should also appear (depending on the 
agreement with the purchaser of the plasma). Donation type may be 0 (zero), 
(indicating the donation type is not specified); a V (if donor was a volunteer donor); 
an S (volunteer source donor); or s (paid source donor). Test results should display 
in the lower right quadrant. The printing of VOLUNTEER DONOR or PAID DONOR 
in the upper left quadrant is optional in the US. 
 
The type of donor must be clearly described on the label. The specific wording is 
not standardized, but the table below lists acceptable phrases. 
 
Table 10  Source Donor Type Text 
 
Type of Donor  Examples of  Phrases  
Normal Donor   Plasma collected from a normal donor 
 Collected from a normal donor 
 Normal donor 
Donor with   Pre-existing antibody ___________ 
Pre-Existing   Collected from a donor with pre-existing antibody/ies to ________ 
Antibodies   Collected from a donor with pre-existing ___________ 
antibody/ies 
 From donor with pre-existing _________ antibody/ies 
Immunized Donors   From donor immunized with ___________ 
(includes vaccine   Immunizing antigen used ____________ 
and RBCs)   Plasma collected from immunized donor. Immunizing antigen 
____________ 
 Collected from donor immunized with __________ 
Disease State   Collected from donor with known Factor ______ Deficiency 
Donors   Collected from donor with pre-existing __________ antibody/ies 
 Collected from donor with ______________ 
 Plasma collected from donor with ___________ 
 Collected from a donor on _____________ 
High Risk Donors   Collected from donor who is ________ reactive/positive 
 Collected from donor who is reactive/positive for ________ 
 Collected from donor with _________ 
antibody/antigen/DNA/RNA 
 Collected from donor known to be reactive/positive for ________ 
 
Note  test statement on label must also be amended to include the 
correct test results for the specific donor. 
 
 
 
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  US Consensus Standard, Version 3.0.0    136 
Figure 95  Source Plasma 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: The presence of the collection date on the label is dependent on the 
agreement with the purchaser. 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    137 
7.9.16  Source Leukocytes 
 
Source leukocytes may be produced from whole blood or by apheresis. The name 
of the product is the same regardless of how it was collected. 
 
The storage temperature of Source Leukocytes varies, depending on the 
agreement with the purchaser. If the product is to be stored at 1 to 6 C or 1 to 10 C, 
it is coded as refg in the core conditions; the label text, however, must indicate 
the actual range for appropriate storage temperature. 
 
Figure 96  Source Leukocytes from Whole Blood 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    138 
 
Figure 97  Source Leukocytes Collected by Apheresis 
 
 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    139 
 
7.9.17  Therapeutic Plasma for Manufacture 
 
This label is similar to other labels for plasma for manufacture, but shall include the 
diagnosis of the patient in the lower left quadrant. 
 
Facilities may eliminate the donor's disease from the label if the facility has been 
granted approval from FDA for an alternative procedure to 21 CFR 640.3(d) under 
the provisions of 21 CFR 640.120 to distribute Whole Blood and blood 
components collected from individuals with diagnosed hereditary 
hemochromatosis without indicating the donors disorder on the container label. 
 
Figure 98  Therapeutic Plasma for Manufacture into Noninjectable Products (Lower Quadrants) 
 
 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    140 
 
7.9.18  Additional Labeling by a Facility Modifying a Blood 
Product 
 
21 CFR 606.121 (c) (13) (iii) requires that certain information be machine readable. 
This includes: unique facility identifier, lot number relating to the donor (called 
Donation Identification Number in this document), ABO/Rh of the donor, and 
Product Code. This applies to facilities modifying units collected at other facilities. 
The product description label on the blood product shall reflect the modification 
(with the exception of when frozen plasma is thawed and used within its 6-24 hour 
time frame or cryoprecipitated AHF products are thawed and used within their 4 or 
6 hour time frame).  
 
Donation Identification Number (DIN): The DIN should remain that of the collection 
facility unless the product is pooled (see 7.8.2, page 115 on Reconstituted Red 
Cells for another exception). If the product is pooled, a unique pool number (in the 
same format as the DIN) shall be assigned by the pooling facility. The name 
beneath the DIN in text must correspond to the Facility Identification Number within 
the DIN. 
 
If the DIN of the original collection facility is used on the product, the name and 
location of the modifying facility must appear in the lower right quadrant if the 
product leaves the facility, per AABB Standards. Only one facility identification has 
to be machine readable, and this is the one reflected in the DIN. Therefore a 
machine readable version of the modifying facility identification is not required in 
the lower right quadrant.  
 
The name and location of the modifying facility is optional on the label if the unit will 
not leave the facility in which it was modified. 
 
Whenever the name and location of a collection or modifying facility appear, the 
FDA registration number (or a unique facility identifier) should also appear. 
 
7.9.18.1  FDA License Number 
 
The Guidance for Industry Cooperative Manufacturing Arrangements for 
Licensed Biologicals (2008) requires the names and FDA license numbers 
of both the collection and modifying facility on a product if both are licensed 
to perform their part of the manufacturing. Please refer to this FDA 
guidance document for detailed information. 
 
If the final product is not licensed, no FDA license numbers should appear 
on the label (i.e., the license number of the collecting facility should be 
crossed out). Licensure status of the component, and appropriate labeling 
based on this, can be determined from Table 11 and Table 12. 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    141 
 
 
Table 11  Licensure Status of Component 
 
Beginning Product  Status of firm performing product  Final status of product 
Status   modification 
Licensed product  Licensed firm approved for a specific  Licensed product (see Table 12 for 
manufacturing step  labeling instructions) 
Licensed product  Unlicensed firm/Licensed firm not  Unlicensed product  
approved for a specific manufacturing 
step 
Unlicensed product  Licensed firm/Unlicensed firm  Unlicensed product 
 
 
Table 12  Appropriate Labeling of Licensed Products 
 
Scenarios  Should the FDA license number of  Additional information 
both manufacturers be on the 
label? 
Final product used in-house  No, not required  Records should indicate when and 
only  where product modification occurred 
Final product distributed out  Yes, the label should show both  Name, location, FDA registration 
of facility (both in-state and  who collected the product and who  number (and FDA license number if 
out-of-state)  performed the product  applicable) of the facility performing 
modification  the product modification should be in 
the lower right quadrant 
Product modification  No, contractors information does  Records should indicate when and 
performed by a contractor  not need to be on the label  where product modification occurred 
and product is used either 
in-house or distributed out of 
the facility 
 
7.9.18.2  Over-labeling: 
 
ISBT 128 labels were designed to be applied as 50 mm x 50 mm (2 x 2) 
quadrant labels, 50 mm x 100 mm (2 x 4) two-quadrant labels (either 
vertically or horizontally), or as a full 100 mm x 100 mm (4 x 4) label. 
These options apply to over-labeling when modifying products. However, 
AABB Standards preclude obscuring, altering, or removing the DIN by 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    142 
facilities that subsequently handle the unit so a full 100 mm x 100 mm label 
will need a cut-out to prevent over-labeling the DIN.  
 
Figure 99, page 142, gives an example of a product that was collected by 
one facility and modified (irradiated) by a second facility when the resulting 
product is not FDA licensed. Phrases such as Further processed by or 
Irradiated by are not required above the name of the modifying facility. 
 
When the only modification of the product is to divide it, as done for 
pediatric aliquots, the FDA license number of the collection/processing 
center may remain on the label, but this is not required. 
 
 Figure 99  Product Modified by a Facility other than the Collection Facility  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Notes:  
The name of the modifying facility in the lower right quadrant is required 
ONLY if the product leaves the modifying facility. 
 
The US license number is crossed-out when the product has been modified 
from the original licensed product and the resulting product is not FDA 
licensed. 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    143 
7.10 Intended Recipient Information Label  
   
Figure 100  Intended Recipient Information Label Examples 
   
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Intended Recipient Information Label should be placed on the front of the container, 
immediately above the Donation Identification Number and ABO/Rh Blood Groups bar 
codes (unless it is a platelet bag) or on a tie tag. (Note: On a platelet storage bag it may be 
inappropriate to place a label in the area above the base label because it reduces the 
breathable area for platelet storage and could result in decreased platelet viability. Please 
consult the manufacturer of the bag for guidance.)  Either of these label examples (or 
other designs with similar information) could be used. The minimum information on the tag 
is defined by the collection facility based on requirements of accrediting organizations. 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    144 
 
7.11 Additional Emergency Release Label  
 
In addition to the label in the upper right quadrant indicating a product is being released 
under emergency conditions, a tie tag should indicate which tests have and have not been 
performed. Below is an example of such a tie tag; however, the label does not have to 
follow this format and any format with this information would be acceptable. This 
information may also be placed in the lower right quadrant of the affixed label. 
 
 
Figure 101  Emergency Release Test Results Tie Tag or Label  
 
 
 
 
 
 
 
 
 
    
 
 
 
 
 
7.12 Unexpected Antibodies 
 
While the presence of unexpected antibodies in the unit is not bar coded on the label, it 
may appear as additional text in the lower right quadrant of the label. This information may 
also appear on a tie tag attached to the unit. 
 
 
Figure 102  Labeling for Unexpected Antibodies  
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    145 
 
8 ICCBBA Databases 
 
ICCBBA maintains the ISBT 128 database tables using Microsoft Access or Microsoft Excel.  
 
8.1  Facility Identification Number  
 
This database contains the names and locations of all ICCBBA-registered facilities 
worldwide. Each facility is assigned a five-character Facility Identification Number (FIN) 
that for US facilities begins with W. This database is found on the ICCBBA Website (you 
must be from an ICCBBA-licensed facility to access this database) and is called:  
 
Registered Facilities  xls 
 
It is also available on the Website as a tab delimited text file (Registered Facilities  Text). 
 
When a US facility registers with ICCBBA, it is important that it provides ICCBBA with its 
full legal name. For an FDA licensed facility, this should be the name and location as it 
appears on the FDA license. For a facility that is FDA registered but not licensed, it should 
be the legal name and location as it appears on the FDA registration. 
 
A look-up tool is available on the ICCBBA Website for identifying the facility associated 
with a given FIN. 
 
8.2  Product Description Code 
 
This database provides a list of all Product Description Codes and their descriptions. A 
detailed description of the ISBT 128 Product Description Code database can be found in 
the document Use of Product Code Data Structure [003]  Blood. The database is found 
on the ICCBBA Website (you must be from an ICCBBA-licensed facility to access this 
database) and is called: 
 
Product Description Codes Database - Access 2000 
 
Comma-delimited text files of each of the tables in the Product Description Code 
Database (Attribute Text File, Class Text File, Product Description Codes Database Text 
File, and Version Text File) are also provided to permit end-users to incorporate these 
tables into any preferred database application. 
 
For ICCBBA licensed facilities, a look-up tool is available on the ICCBBA Website for 
finding Product Description Codes using this database. 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    146 
8.3  Special Testing: General 
 
This database contains the test names and codes for data conveyed in the Special 
Testing Data Structure (Data Structure 010) such as CMV and Hemoglobin S. The 
database is found on the ICCBBA Website (you must be from an ICCBBA-licensed facility 
to access this database) and is called: 
  
Special Testing General - Access 2000 
 
A comma-delimited text file of the table in the Special Testing: General database (Special 
Testing General Text) is also provided to permit end-users to incorporate this table into 
any preferred database application. 
 
8.4  Manufacturer Identification Codes 
 
The table contains the identification codes assigned to manufacturers for use in the 
Container Manufacturer and Catalog Number (Data structure 017) and the Manufacturer 
and Catalog Number - Items other than Containers (Data structure 021). Some of the 
entries may not be in current use but are retained for use in look back situations. Licensed 
vendors who wish to have a code assigned for use in these data structures should contact 
ICCBBA. This database is published on the ICCBBA Website. This table is named:  
 
Table W1 Manufacturer ID Codes [RT016] 
 
8.5  Structured Compound Messages 
 
The table contains the reference numbers and structures for structured ISBT 128 
compound messages. When using these messages, the data identifier is incorporated into 
the compound message structure. Requests for additions to this table should be 
submitted through the ICCBBA office. This database is published on the ICCBBA Website. 
This table is named:  
 
Table W2 Structured Compound Messages [RT017] 
 
 2013 ICCBBA   All rights reserved  www.iccbba.org 
   
  US Consensus Standard, Version 3.0.0    147 
 
9 Appendix Acceptable 
Abbreviations for Blood Label 
Text 
 
Ab  antibody(ies) 
ACD  Acid Citrate Dextrose 
ACD-A  Acid Citrate Dextrose Formula A 
ACD-B  Acid Citrate Dextrose Formula B 
Approx  approximately 
C  degree(s) Celsius (Centigrade) 
CMV  Cytomegalovirus 
CPD  Citrate Phosphate Dextrose 
CPDA-1  Citrate Phosphate Dextrose Adenine 
Formula 1 
CP2D  Citrate Phosphate Double Dextrose 
DNA  Deoxyribonucleic Acid 
E11 (for any exponents)  X1011 
g  gram(s) 
h  hour(s) 
HBc  Hepatitis B Core  
HBsAg  Hepatitis B Surface Antigen 
HBV  Hepatitis B Virus 
HCV  Hepatitis C Virus 
HIV  Human Immunodeficiency Viruses 
HgbS  Hemoglobin S 
HLA  Human Leukocyte Antigen 
HTLV  Human T-cell Lymphotropic Viruses 
mg  milligram(s) 
mL  milliliter(s) 
Na  sodium 
Neg.  negative 
PAS  Platelet Additive Solution 
RNA  Ribonucleic Acid 
room temp  room temperature 
STS  serological test for syphilis 
FDA Reg. No.  FDA Registration Number 
US Lic.  US License Number 
WNV  West Nile virus 
 
 
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Glossary 
Attribute  Information about the processing or other characteristics of a blood 
component beyond Class and Modifier.   
Autologous collection  Blood collected from the intended recipient. 
Base label  The label applied by the manufacturer to: (1) primary and satellite 
containers for the collection of Whole Blood; (2) apheresis collection 
containers; and (3) transfer containers. 
Class  A general description of a product (such as Whole Blood, Red Blood Cells, 
or Fresh Frozen Plasma). 
Concatenation  A method by which the information held in two bar codes is combined in 
the scanner into a single string of data before being sent to the host 
computer. ISBT 128 places specific rules on the operation of 
concatenation which ensures that the two codes are adjacent to one 
another, hence allowing this feature to be used in label process control.  
Core conditions  The anticoagulant and/or additive, nominal collection volume, and storage 
temperature requirements for a blood component. 
Data characters  The individual ASCII characters that make up the data content. 
Data content  The characters in a data structure that encode the information for which 
the data structure is named. The data content does not include the data 
identifiers. 
Data identifier  The first two characters in a data structure that identify the data              
structure. These will always be present when the data structure is used as 
a bar code, but may be omitted when the data structure is used in 
situations in which the data structure identity is unambiguously and 
explicitly defined. 
Dedicated collection  A collection arranged by the collecting facility to support a specific 
recipient on a frequent basis (for example, to ensure limited exposure to 
allogeneic products). This term may be used when donors are authorized 
by a medical director to give blood more frequently than the routine 
interval between donations in order to support a particular patient. An 
example would be when a parent is donating low volume units to support 
an infant. 
Designated collection  A unit collected from a donor called by the collecting facility to provide (a) 
product(s) to be used by a specific recipient in some future therapeutic 
procedure. An example would be when an HLA-compatible donor is 
recruited to meet the specific needs a patient with antibodies to HLA 
antigens.  
Directed collection  A unit collected from a donor who presents to the collecting facility at the 
request of another person intending to provide (a) product(s) to be used by 
that person in some future therapeutic procedure.  
Final label  The label that appears on a blood product ready for release. 
 
 
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Flag character  Part of the data content of a data structure used in process control or data 
transmission checking. For ISBT 128, flag characters are used with the 
Donation Identification Number. They are printed in eye-readable format, 
but distinguished in some manner from the representation of the other 
data characters. 
Modifier  A description that relates to the Core Conditions of a blood component and 
distinguishes it from other members of the same Class (such as 
Apheresis, Frozen, Frozen Rejuvenated, or Washed). 
Platelet apheresis  Note: The following terminology is specific to US apheresis manufacturing 
terminology  and may not represent use of these words in other contexts (including 
other ISBT 128 contexts). 
Reference: 
Guidance for Industry and FDA Review Staff: Collection of Platelets by 
Automated Methods (December 2007) 
Single Platelet  A type of collection that results in one transfusable apheresis platelets 
Apheresis  component with a platelet yield of either 3 x 1011 or <3 x 1011(low yield). 
Collection   
   
Double Platelet  A type of collection that results in two equal transfusable apheresis 
Apheresis  platelets components, each with platelet yields of 3 x 1011 (1st and 2nd 
Collection  Containers). The two components may have either been collected during 
  the apheresis process or produced by the post-collection separation 
  (splitting) of the single parent container. 
   
Triple Platelet  A type of collection that results in three equal transfusable apheresis 
Apheresis   platelets components, each with platelet yields of 3 x 1011 produced by 
Collection  the post-collection separation (splitting) of the single parent container (1st, 
  2nd and 3rd Containers). 
   
Divided Platelet  A component that results from the separation (division) of a transfusable 
Apheresis  apheresis platelets component obtained from a single, double or triple 
Component  collection into components with lower volumes and yields. The resulting 
  components are designated with alpha characters in position 7 of the ISBT 
128 Product Code (e.g., A0 or B0). If a divided component is again 
divided, position 8 of the ISBT 128 Product Code would be changed to the 
appropriate lower case letter (e.g., Aa or Ab). Divided components may 
have platelet yields that are either 3 x 1011 or <3 x 1011 (low yield).  
(Note: This definition applies only to divided apheresis platelets. The term 
divided may be used with other components for which this definition does 
not apply.) 
Primary container  The container in which the anticoagulant is placed for whole blood 
collection. 
Satellite container  Any container, often empty, attached by the manufacturer to a primary 
container as part of a Whole Blood collection set intended to contain 
Platelets, Plasma, or Cryoprecipitated AHF. 
 
 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org  US Consensus Standard, Version 3.0.0    150 
Text  See Figure 103, page 151. 
Data content text  The representation of the data characters in a bar code in letters or        
numbers (printed left justified immediately below the bar code, unless 
otherwise specified).  
Bar code text  The interpretation of the data content text (the data content of the bar 
code) that generally requires a look-up table.  
Additional text  All other information on the label that is not associated with a bar code.  
Transfer container  Any container that is not an integral part of a Whole Blood or apheresis 
collection set intended for a blood product. 
 
 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org  US Consensus Standard, Version 3.0.0    151 
 
Figure 103  Text Terminology in ISBT 128 Documents 
Additional text 
Data content text 
Bar code text 
 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org  US Consensus Standard, Version 3.0.0    152 
 
Index 
2-D symbologies, 28  Facility identification number, 145 
AABB, 30  ICCBBA databases, 145 
Abbreviations, 9, 147  Manufacturer identification code, 146 
ABO  Product description code, 145 
Data Structure Index, 22  Special testing, 146 
ABO/Rh  Structured compound message, 146 
Collection intended use, 35  Database tables 
Data structure, 34  Special testing general, 146 
Donation type, 35  Deglycerolized red cells, 121 
Tables, 37  Delivery mechanisms, 28 
Acronyms, 9  Designated donation 
Additional label information, 17, 81  Definition, 148 
Additional text  Directed donation 
Definition, 150  Definition, 148 
Apheresis  Directed donor ineligible for crossover, 102 
Fresh frozen plasma, 124  Divided products, 118 
Thawed fresh frozen plasma, 126  Divisions 
Attribute  Product code, 41 
Definition, 148  Donation identification number 
Autologous Donor, 102  Data structure, 31 
Bar code text  Encoding the year, 33 
Definition, 150  Flag characters, 33 
Base label, 94  Donation type 
Illustration, 96, 97  ABO/Rh data structure, 35 
Bombay, 103  Codes in product code data structure, 91 
Check character  Example product code label, 44 
Donation identification number, 33  Emergency release, 103, 144 
Code 128, 28  Expiration Date 
Collection Date  Data Structure Index, 22 
Data Structure Index, 22  Facility identification number database, 145 
Collection date and time date structure, 50  FDA, 30 
Collection date data structure, 48  Flag characters 
Concatenation, 27  Donation identification number, 33 
Container manufacturer information, 95  Frozen red cells, 120 
Data content, 20  Granulocytes, 121 
Data content text  HLA 
Definition, 150  Data Structure index, 23 
Data identifiers, 20  Intended recipient labels, 143 
Data Identifiers  Label design 
Data Structures Index, 22  Lower right quadrant, 59 
Data structure  Principles, 52 
ABO/Rh, 34  Quadrants, 61, 62 
Collection date, 48  Size, 53 
Collection date and time, 50  Upper left quadrant, 55 
Donation identification number, 31  Upper right quadrant, 58 
Product code, 40, 46  Label example 
Special testing/general, 51  ABO/Rh, 103 
Special testing/platelet HLA and platelet  Apheresis FFP open system, 124 
specific antigens, 51  Bar code positions, 26 
Special testing/red blood cell antigens, 51  Base label satellite container, 96 
Data structures, 20  Data content, 21 
Database  data content text donation type, 44 
 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org  US Consensus Standard, Version 3.0.0    153 
Divided product, 118  Intended use, 43 
Granulocytes untested, 121  Proper name, 42 
Intended recipient, 143  Requesting new codes, 45 
Platelets with bacterial test or monitoring, 127  Product description code database, 145 
Pooled products, 113  Product description labels, 63, 104 
Product code text layout, 65  Proper names of components, 67 
Product codes, 104  Radio frequency identification tags, 29 
Reconstituted red cells, 116  Reconstituted red cells, 115 
Recovered plasma, 133  Reconstituted whole blood. See Reconstituted Red 
Small satellite container, 97  Cells 
Source plasma, 136  Recovered plasma, 133 
Special testing, 109  RFID. See Radio frequency identification tags 
Thawed FFP, 123  RhD 
Thawed plasma manually changed expiration,  Data Structure Index, 22 
123  Satellite container label 
Upper right quadrant, 59  Illustration, 99 
Label text  Source plasma, 135 
Additional information, 81  Special testing 
Attributes, 74  General data structure, 51 
Donation type in product code, 91  Red blood cell antigens data structure, 51 
General rules, 63  Special testing database, 146 
Proper names, 67  Special testing labels, 109 
Recovered plasma, 89, 133  Structured compound message database, 146 
Manufacturer identification code database, 146  Thawed Apheresis, 126 
Modifying facility, 140  Thawed plasma products, 122 
Para-Bombay, 103  Therapeutic collection ABO/Rh label, 103 
Platelet and HLA  Upper left quadrant, 55 
Data structure, 51  Upper right quadrant 
Platelets with bacterial monitoring or testing, 127,  Bombay and para-Bompay, 103 
128  Directed donor ineligible for crossover, 102 
Pooled products, 112  Emergency release, 103 
Product code  Illustration, 102 
Attributes, 43  Label example, 59 
Data structure, 46  Therapeutic, 103 
Divisions, 41, 44  Washed red cells, 121 
Donation type text, 91 
Donation types example label, 44 
 
 
 
 
 2013   ICCBBA   All rights reserved  www.iccbba.org