Statement from FDA's Donald St. Pierre on findings from ongoing investigation into lead testing issues

SILVER SPRING, Md., March 22, 2018 /PRNewswire-USNewswire/ -- When the U.S. Food and Drug Administration first warned Americans in May 2017 that lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the U.S., the agency made a commitment to continue to aggressively investigate the problem. Since then, the FDA has remained in close contact with the lead test manufacturer as well as Becton Dickinson (BD) & Company, the manufacturer of certain blood sample collection tubes often used alongside many lead tests, as part of our effort to determine the cause of the inaccurate results.

At the FDA's request, BD conducted studies to assess the accuracy of Magellan's LeadCare testing systems when used with blood from the vein (venous) collected into BD tubes. The FDA concluded that the studies performed by BD were robust and showed that there was a significant chance of false results with Magellan's LeadCare tests when used with whole blood collected from the vein and stored in certain BD tubes. Upon further investigation, BD determined that the affected tubes' rubber stoppers contain a chemical called thiuram that can release sulfur-containing gases that dissolve into blood samples 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 a sample.

Given these findings, the FDA continues to recommend that Magellan lead tests not be used with blood samples taken from the vein. Magellan's lead test systems can continue to be used with blood samples from a finger or heel stick (capillary blood samples).

BD has determined their venous blood collection tubes that contain thiuram and that could be used with Magellan lead tests include those with green tops (lithium heparin tubes), pink, tan, and lavender tops (EDTA tubes). Because the chemical thiuram may be used to manufacture rubber stoppers by both BD and other blood collection tube manufacturers, the recommendation not to use Magellan lead tests with blood samples taken from the vein applies to all brands of collection tubes used for blood drawn from the vein. The FDA is following up with blood collection tube manufacturers serving the U.S. market to investigate if this issue may impact collection tubes marketed by companies other than BD. The FDA is also continuing to evaluate other factors that may have contributed to inaccurate results observed with Magellan lead tests.

Lead exposure can affect nearly every system in the body, produces no obvious symptoms, and frequently goes unrecognized, potentially leading to serious health issues. Lead poisoning is particularly dangerous to infants and young children. While recommendations for lead screening in adults differ from state to state, all states require children to be screened for lead exposure. Some adults are also at risk for lead exposure, including those who work around products or materials that contain lead. 

BD uses thiuram in the manufacturing of green tops (lithium heparin tubes), red tops (serum tubes), grey tops (sodium fluoride tubes), pink, tan and lavender tops (EDTA tubes), black tops (seditainer tubes), light blue/black tops (CPT tubes), and green/red tops (CPT tubes). At the 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. This evaluation is ongoing. Based on the results of BD's studies to date and our understanding of the chemical interaction that could cause inaccurate lead test results, the FDA does not believe that there is evidence at this time showing that other tests are impacted by the chemical interference. The FDA also has no evidence at this time that other methods of measuring blood lead, including mass spectrometry or atomic absorption method lead tests, are affected by the thiuram interference.

The FDA continues to work alongside the U.S. Centers for Disease Control and Prevention (CDC) on an independent analysis of Magellan Diagnostics' LeadCare System tests. Given that studies are ongoing,  patients are encouraged to continue following the CDC's 2017 re-testing recommendations and the FDA's recommendations for health care professionals. As our investigation into the cause of the inaccurate lead test results continues to unfold, the FDA will provide updates on our findings and on changes to our recommendations based on any new findings.

For more information:

• FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
• FDA: Safety Issue on Magellan Diagnostics LeadCare Testing Systems
• FDA: Status update on FDA's investigation of BD regarding inaccurate results from certain lead tests
• FDA: Warning to Americans about risk of inaccurate results from certain lead tests
• CDC: Lead
• CDC: Potential for Falsely Low Blood Lead Test Results from LeadCare Analyzers

Donald St. Pierre is the acting director of the Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, FDA.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration