FDA Warning Letter Regarding Lead Testing Issues

PUBLISHED: Jan 15, 2018
Relevant to: Ambulatory Care, Behavioral Health, Clinical Lab, Critical Access Hospitals, Hospitals, Long Term Care, Medical Office

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Becton Dickinson (BD) & Company that cited several violations of federal law, including marketing significantly modified versions of certain BD Vacutainer blood collection tubes without required FDA clearance or approval and failing to submit medical device reports to the FDA within the required timeframe. These violations were discovered through an inspection of BD’s New Jersey facility. The inspection also showed that the company failed to evaluate and investigate a complaint involving variability in test results observed when certain BD Vacutainer blood collection tubes were used with Magellan Diagnostics’ LeadCare test systems.

The FDA conducted its inspection of the BD facility as part of its ongoing investigation into the cause of inaccurate blood lead test results associated with Magellan’s LeadCare test systems.

At this time, the FDA does not have evidence showing that other blood tests are adversely affected when BD blood collection tubes are used, and these tubes remain on the market. They are actively communicating with BD about their investigation into this matter and will continue to keep the public informed.

BD has until February 1, 2018 to notify the FDA about specific steps the company has taken to address these violations and to prevent them from recurring. If the company fails to promptly correct these violations, the FDA may take additional action, such as seizure, injunction and civil money penalties.

The FDA continues to encourage people to follow the Centers for Disease Control and Prevention's (CDC) re-testing recommendations and the FDA's recommendations for health care professionals. In addition, the agency is continuing the investigation into the root cause of the inaccurate lead test results and working with the CDC on an independent analysis of Magellan Diagnostics’ LeadCare System tests and BD collection tubes.

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