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                Tests Used In Clinical Care

Tests Used In Clinical Care

                        Safety Issue on Magellan Diagnostics LeadCare Testing Systems Home
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          Safety Issue on Magellan Diagnostics LeadCare Testing SystemsTests Used In Clinical Care Safety Issue on Magellan Diagnostics LeadCare Testing Systems
  
  	
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    PrintFDA’s Ongoing Investigation of Inaccurate Result Associated with LeadCare Testing Systems

Based on data provided by Becton Dickinson & Company (BD), the FDA has concluded that one of the contributing factors to the inaccurate LeadCare test results is the chemical composition of the rubber stoppers of certain blood collection tubes.

Upon FDA’s request, BD conducted studies to assess the accuracy of Magellan’s LeadCare testing systems when used with venous blood collected into BD venous blood tubes. The FDA concluded that the studies performed by BD were robust and showed that there was a significant chance of incorrect results with Magellan’s LeadCare tests when used with venous whole blood collected in certain BD blood tubes. Upon further investigation, BD determined that the affected tubes' rubber stoppers contain a chemical called thiuram that can release reactive gases, carbon disulfide (CS2) and carbonyl sulfide (COS), which can dissolve into the blood sample and bind tightly to lead particles. This chemical reaction makes it difficult for the Magellan lead tests to detect the correct amount of lead in the sample.

There are several BD blood collection tubes that contain thiuram and that could be used with the Magellan lead tests including the BD Vacutainer® EDTA Lavender Top, Tan Top, Pink Top tubes and BD Vacutainer® Lithium Heparin Green Top tubes. At FDA’s request, BD is conducting testing to determine whether clinical laboratory tests other than the Magellan lead tests are affected by the thiuram chemical interference. Based on the results of BD’s studies to date and our understanding of the mechanism of the interference, the FDA does not believe there is evidence showing that other clinical laboratory test results are impacted by the thiuram chemical interference at this time. BD is notifying their customers about this information.

Thiuram may be used by manufacturers other than BD to manufacture rubber stoppers for blood collection. The FDA is following up with manufacturers of blood tubes marketed in the U.S. to investigate this issue. The FDA continues to recommend that venous samples not be used with Magellan lead tests. This recommendation applies to all venous blood collection tubes. Capillary blood may continue to be tested with the Magellan lead tests.

The agency is still aggressively investigating this issue, including reviewing data from investigations performed by Magellan Diagnostics and BD, requesting additional information from relevant manufacturers regarding the issue, performing inspections as needed, and having additional independent studies performed. We will continue to update this webpage with critical information as necessary.

Background Information on LeadCare Lead Testing System Safety Issue

Magellan Diagnostics Inc. manufactures the following lead testing systems: LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra. The LeadCare Testing Systems detect the amount of lead in a blood sample obtained from finger or heel prick (capillary) or from a vein (venous). On May 17, 2017, the FDA issued a warning regarding all four Magellan Diagnostics LeadCare Testing Systems when processing venous blood samples, in the United States. There are other methods of blood lead testing available, e.g. inductively coupled plasma-mass spectrometry (ICP-MS) or graphite furnace atomic absorption spectroscopy (GFAAS), but these test methods are typically only run in a large-capacity laboratory.

The FDA continues to warn laboratories and health care professionals that they should no longer use Magellan Diagnostics Inc.’s LeadCare System tests with venous blood samples. All four LeadCare Testing Systems marketed in the U.S. are affected by this warning: LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra. The FDA has no evidence at this time that other methods of lead testing such as mass spectrometry or atomic absorption are affected by this issue.

Magellan LeadCare testing systems may underestimate blood lead levels (BLLs) and give inaccurate results when processing venous blood samples. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.

At this time, the FDA does not have evidence that Magellan’s LeadCare Testing Systems have the same problem when processing capillary blood samples, which are more commonly used in young children.

FDA Activities:

On May 17, 2017, the FDA issued a Safety Communication - FDA Warns Against Using Magellan Diagnostics LeadCare Testing Systems with Blood Obtained from a Vein: FDA Safety Communication - to warn laboratories and health care providers not to use Magellan Diagnostics Inc. LeadCare Systems tests with venous blood samples.
	On June 29, 2017, the FDA completed an inspection at Magellan Diagnostics’ manufacturing facility. The detailed observations from the inspection can be found in the Form 483 issued at the conclusion of the inspection.
	On July 6, 2017, the FDA completed an inspection at Becton Dickinson (BD) & Company's manufacturing facility. The detailed observations from the inspection can be found in the Form 483 issued at the conclusion of the inspection.
	The FDA issues a Form 483 after a facility inspection if an investigator has observed any conditions that, in the investigator’s judgment, may be violations of federal law (e.g., the Federal Food, Drug and Cosmetic Act). The observations do not represent a final decision by FDA about the facility’s compliance. For more information on FDA’s Form 483 visit the FDA Form 483 Frequently Asked Questions webpage.
	On October 23, 2017, the FDA issued a warning letter to Magellan Diagnostics Inc. for violations based on the agency’s review of the evidence from the inspection at Magellan’s facility.
	On January 11, 2018, the FDA issued a warning letter to Becton Dickinson (BD) Company for violations based on the agency’s review of the evidence from the inspection at BD’s facility.Information for Health Care Providers and Health Care Facilities

The FDA continues to recommend that laboratories and health care professionals review the Safety Communication and:

Discontinue using Magellan Diagnostics’ LeadCare System tests with venous blood samples. At this time, all LeadCare Systems can be used with capillary blood samples.
	Report any adverse events to the FDA and to Magellan Diagnostics.
	If laboratories or health care professionals are concerned about using the LeadCare Testing Systems, the alternative options are mass spectrometry or atomic absorption methods. These are not point-of-care tests and may be available only from larger-capacity laboratories, such as reference labs. The FDA has no evidence at this time that these alternative methods of measuring blood lead are affected by the thiuram interference.
	If laboratories identify any problems with using BD or other manufacturer’s collection tubes report them to the FDA and to the manufacturer.At FDA’s request, to assess potential interference of thiuram used in BD Vacutainer® EDTA Lavender Top, Tan Top, Pink Top tubes and BD Vacutainer® Lithium Heparin Green Top tubes with other clinical laboratory tests, BD provided additional data for some analytes using tubes with thiuram versus tubes without thiuram. BD selected tests based on multiple factors such as commonly used analytes, a variety of molecular structures and classes of analytes, and a variety of test instruments/methodologies. The following 44 chemistry tests and immunoassays, 4 immunology tests, and 1 hematology panel (i.e., complete blood count with differential) were assessed.

Chemistry tests and Immunoassays

Alanine aminotransferase (ALT)
			Cholesterol
			Gamma glutamyltransferase (GGT)
			ProgesteroneAlbumin
			Cortisol
			Glucose
			SodiumAlkaline phosphatase
			Creatine kinase (CK)
			High density lipoprotein (HDL)
			TestosteroneAmylase
			Creatine kinase-MB isoenzyme (CK-MB)
			Iron
			Total bilirubin (TBIL)Aspartate aminotransferase (AST)
			Creatinine
			Lactate dehydrogenase (LDH)
			Total prostate specific antigen (PSA)Beta-human chorionic gonadotropin (β-HCG)
			Direct bilirubin (DBIL)
			Lipase
			Total proteinBlood urea nitrogen (BUN)
			Ferritin
			Low density lipoprotein (LDL)
			Total thyroxine (T4)Calcium
			Folate
			Magnesium
			Total triiodothyronine (T3)Carbon dioxide
			Follicle stimulating hormone (FSH)
			Phosphorous
			TriglyceridesChloride
			Free triiodothyronine (T3)
			Potassium
			Uric acidThyroid stimulating hormone (TSH)
			Free thyroxine (T4)
			Troponin
			Vitamin B12

Hematology and Immunology tests

Complement C3
			Complete blood count with differentialImmunoglobulin A (IgA)Immunoglobulin G (IgG)Immunoglobulin M (IgM)

Based on this assessment, there is no evidence that these tests listed above are impacted by the thiuram curing agent. FDA continues to communicate with BD as they complete their investigation with additional tests to evaluate the potential of thiuram interference and to help ensure the tests are representative of commonly used tests in clinical laboratories. Additional tests include metals, cardiac markers, cancer markers, therapeutic drug monitoring tests, and toxicology tests. Laboratories should determine the need to evaluate their tests for the potential of thiuram interference.

In addition, there are several other BD blood collection tubes that contain thiuram, including red top tubes (serum tubes), grey top tubes (sodium fluoride tubes), black top tubes (seditainer tubes), light blue/black top tubes (CPT tubes), and green/red tubes (CPT tubes). Based on the mechanism of interference with thiuram, there is no evidence at this time that tests conducted with these tubes are affected. BD is communicating with FDA to evaluate these tubes.

Information for Patients

The FDA is encouraging parents and at-risk adults to follow CDC’s recommendations listed in its May 17 Health Advisory for any necessary re-testing based on this warning.

Additional Resources

FDA Stakeholder Call Transcript - May 17, 2017 (PDF - 52KB)
	FDA issues warning about Magellan Diagnostics’ LeadCare Testing Systems that may underestimate BLLs and give inaccurate results.
	FDA Safety Communication: FDA Warns Against Using LeadCare Testing Systems with Blood from a Vein
	CDC’s Health Advisory – May 17, 2017
	2015 Medical Device Report (PDF - 931KB)
	2016 Medical Device Report – Received by FDA on May 8, 2017 (PDF - 4.1MB)
	Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results
	Information on Lead Exposure
	Magellan Diagnostics Form 483 (PDF - 2.5MB)
	Becton Dickinson Form 483 (PDF - 1.8MB)
	FDA Statement on Magellan 483 July 13, 2017
	FDA in Brief on BD 483 August 17, 2017
	Magellan Diagnostics, Inc. Warning Letter
	Press Release: FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues
	Press Release: FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
	BD Customer Letter
	BD News Release
	Statement from FDA’s Donald St. Pierre on findings from ongoing investigation into lead testing issues

                                                                                  Content current as of:
      09/27/2018
              
              
Regulated Product(s)
		 Medical DevicesTests Used In Clinical Care

          
                        Safety Issue on Magellan Diagnostics LeadCare Testing Systems
 
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