August 17, 2017
"As part of the FDA’s commitment to understanding what caused the inaccurate results associated with Magellan Diagnostics' LeadCare tests, the agency conducted an inspection of Becton Dickinson (BD) & Company, the manufacturer of certain blood collection tubes used alongside these tests," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. "The FDA’s investigators observed several potential violations of federal law at BD's facility; however, at this time, we have not determined that the BD tubes or any other brand of tube is linked to the cause of the inaccurate lead test results. We are continuing to aggressively investigate the matter."
On May 17, the FDA warned Americans that Magellan's LeadCare test systems performed on blood drawn from the vein (venous) may provide inaccurate results. Prior to this warning, Magellan informed its customers that the inaccurate results may potentially be related to changes in the composition of the top of certain BD blood collection tubes — specifically, tubes with lavender- or tan-colored tops — and advised customers to no longer use these types of tubes with their blood lead tests. As part of the FDA’s investigation into the root cause of the inaccurate lead test results, the FDA conducted an inspection of BD's Franklin Lakes, New Jersey facility. Today the FDA is releasing the report issued at the conclusion of the inspection, which includes several observations that may be violations of federal law. The report does not represent a final agency determination regarding the company’s compliance with the law or any conclusion about whether the root cause of the inaccurate test results is related to BD's blood collection tubes.
The FDA is carefully reviewing the evidence collected during its inspection of BD's facility to determine whether there have been violations of federal law and whether further action is warranted. The FDA will continue to provide updates on our investigation into the inaccurate test results as more is learned. In the meantime, the agency encourages people to continue following the Centers for Disease Control and Prevention's re-testing recommendations and the FDA's recommendations for health care professionals.
For More Information:
- FDA: Safety Issue on Magellan Diagnostics LeadCare Testing Systems
- FDA: Form 483 Issued to Becton Dickinson & Company
- FDA: May 17 news release warning Americans about risk of inaccurate results from certain lead tests
- CDC: Lead
- CDC: Potential for Falsely Low Blood Lead Test Results from LeadCare Analyzers