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Medical Devices / Inspections and Audits

FDA Warns BD Facility in Ongoing Lead Test Probe

Jan. 18, 2018

The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant CGMP violations, as part of its ongoing investigation of inaccurate blood lead test results associated with Magellan’s LeadCare test systems.

The agency’s inspection of the device manufacturer’s Franklin Lakes, New Jersey facility revealed that the firm did not have an approved application for premarket approval for its BD Vacutainer K2EDTA Tubes product, and did not notify the agency of its intent to commercially distribute the product after making significant changes to its rubber stoppers.

 “We are continuing to aggressively investigate this issue, including whether the use of BD tubes led to inaccurate lead test results,” said Donald St. Pierre, CDRH’s acting director of for in vitro diagnostics and radiological health and deputy director of new product evaluation.

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