Official Copy

Approved for Use

Effective Date: 21 Dec 2018

Revision: A

CustomerLetter-26638en

January 2019
Dear Valued Quidel Triage® Customer:

We are pleased to announce the most recent Quidel Triage MeterPro software upgrade, version 5.04.021.
This software upgrade is part of our continuous quality improvement program for the Quidel Triage MeterSystem.
This software upgrade includes:
 New quality measures to improve the Quidel Triage product performance Compatibility with new products
Please note: This software upgrade is mandatory for the use of the Quidel TriageTrue™ High Sensitivity
Troponin I Test.
Please install this upgrade on all Quidel Triage MeterPro instruments in your facility. The instructions forinstalling this software upgrade are included, and the process should take less than 10 minutes. You willneed your Supervisor CODE CHIP™ module to perform the installation. All data and settings should bepreserved, therefore it is not necessary to purge existing data in your Quidel Triage MeterPro prior toinstalling the upgrade.*The Quidel TriageTrue™ High Sensitivity Troponin I Test is not compatible with the Triage MeterPlus
instrument. If you have a Triage MeterPlus instrument, please contact your local Quidel representative formore information.
If you have any questions, please contact Quidel Technical Services at +353 (91) 412 474, or via e-mail atemeatechnicalsupport@quidel.com.
Thank you for your continued use of the Quidel Triage diagnostic assays.

*We have made every effort to ensure that all test data remains intact after the upgrade but in the remote chance thata failure should occur, we recommend that you print any test results required for your records prior to performing thisupgrade. This may be accomplished by printing all results or performing a search and printing all results since the lastdate your records were archived. As the meter memory can hold up to 750 patient test results, you may wish to first
install a fresh roll of paper.

Printed on: 26 Mar 2019, 12:20:08 pm

Official Copy

Approved for Use

Effective Date: 21 Dec 2018

Revision: A

CustomerLetter-26638en

Software Upgrade Installation Instructions

Instruction

Quidel Triage MeterPro Display

1. Turn the Meter on. Allow the Meter to run the self-test.
2. From the Main Menu, select:

INSTALL NEW CODE CHIP

3. Press ENTER, screen will display:

INSERT CODE CHIP

4. Insert the Supervisor CODE CHIP™ module
5. Press ENTER; Meter displays

PLEASE WAIT: READING CODE CHIP
followed by:SUPERVISOR CODE CHIP IN PORT TO LOAD PROGRAMREMOVE IT AND INSERT PROGRAM CODE CHIP

6. Remove the Supervisor CODE CHIP™ module
7. Insert the Software Upgrade CODE CHIP™ module
8. Press ENTER; Meter will display twomessages:

PLEASE WAIT: CHECKING PROGRAM KEY AND VERSION
followed by:
PLEASE WAIT: LOADING PROGRAM

9. The software transfer may take up to 3
minutes.

SOFTWARE UPGRADE SUCCESSFUL

If you receive the message “SOFTWARE UPGRADE UNSUCCESSFUL”, remove the Software Upgrade CODECHIP™ module, reinsert the Software Upgrade CODE CHIP™ module and repeat this process.
10. Press ENTER
The Meter will perform a System Test. During this test, the software version will be displayed in the lower left
corner, and then it returns to the Main Menu. This 6-digit number should match the number on yourSoftware Upgrade CODE CHIP™ module.
11. Remove the Software Upgrade CODE CHIP™ module.
12. Run the QC Device.
If you have any questions, please contact Quidel Technical Services at +353 (91) 412 474.

Printed on: 26 Mar 2019, 12:20:08 pm

Official Copy

Approved for Use

Effective Date: 21 Dec 2018

Revision: A

Signature Manifest
Document Number: CustomerLetter-26638en
Title: Quidel Triage® MeterPro software upgrade letter For Software Version 5.04.021
All dates and times are in US/Pacific.

ECO-6015 T2 CustomerLetter-26638en TechBulletin-26641en CR-8013

Collaboration
Name/Signature

Title

Alyna Fainberg (AFAINBERG)

Date

Meaning/Reason

06 Dec 2018, 06:29:57 PM

Complete

Justin Stelzer (STELZJU)

Project Manager

07 Dec 2018, 08:23:04 AM

Complete

Alexander Taam
(ALEXANDER.TAAM)ACT Program Lead

07 Dec 2018, 08:44:56 AM

Complete

Payal Aggarwal-Scott (PAYALAS) Quality Assurance Engineer V

07 Dec 2018, 10:13:32 AM

Complete

Jacqueline Paulo-Kretzer(JACQUELINE.KRETZER)

07 Dec 2018, 10:20:14 AM

Complete

Laura DuPont (LAURA.DUPONT) Training Systems Administrator

07 Dec 2018, 11:41:09 AM

CompleteDawn Allenby (ALLENDA)

Associate Director,Regulatory

07 Dec 2018, 02:11:15 PM

Complete

Billy Zarcone (BILLY.ZARCONE)

Access Only

07 Dec 2018, 03:18:06 PM

Complete

07 Dec 2018, 03:54:17 PM

CompleteDocument Control Analyst

07 Dec 2018, 04:20:17 PM

Complete

Title

Date

Meaning/Reason

Technical Marketing Manager

Jody Vacala (JODY.VACALA)
Deborah Phillips (PHILLDE)

Approvals
Name/Signature

Payal Aggarwal-Scott (PAYALAS) Quality Assurance Engineer V

07 Dec 2018, 04:30:55 PM

Approved

Jody Vacala (JODY.VACALA)

07 Dec 2018, 04:50:07 PM

Approved

Alexander Taam
(ALEXANDER.TAAM)ACT Program Lead

08 Dec 2018, 11:05:00 AM

Approved

Justin Stelzer (STELZJU)

Project Manager

10 Dec 2018, 09:37:38 AM

Approved

Jacqueline Paulo-Kretzer(JACQUELINE.KRETZER)

Technical Marketing Manager

11 Dec 2018, 02:59:51 AM

Approved

Dawn Allenby (ALLENDA)

Associate Director,Regulatory

11 Dec 2018, 01:55:39 PM

Approved

Alyna Fainberg (AFAINBERG)

14 Dec 2018, 02:59:41 AM

Approved

Nenita Trinidad (TRININE)

Manager, Manufacturing I

21 Dec 2018, 05:16:22 PM

Approved

Deborah Phillips (PHILLDE)

Document Control Analyst

21 Dec 2018, 06:57:10 PM

Approved

Title

Date

Meaning/Reason

DMR
Name/Signature
Erwin Gobaleza(ERWIN.GOBALEZA)

Document Control Analyst

Deborah Phillips (PHILLDE)

Document Control Analyst

21 Dec 2018, 07:01:00 PM

Approved

TitleDate

Meaning/Reason

Document Control Analyst

21 Dec 2018, 07:01:18 PM

Approved

Final Release
Name/Signature
Deborah Phillips (PHILLDE)

Printed on: 26 Mar 2019, 12:20:08 pm

Revision: A