The Food and Drug Administration (FDA) has issued a warning letter to Becton Dickinson (BD) alleging several violations of federal law. FDA said it discovered these violations during an inspection of BD’s New Jersey facility that was part of the agency’s ongoing investigation into the cause of inaccurate results associated with Magellan’s LeadCare test systems. According to FDA, BD’s violations include 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 FDA within the required timeframe. FDA also said the inspection found 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. At this time, however, FDA does not have evidence that BD blood collection tubes adversely affect other blood tests and has allowed the tubes to remain on the market.
BD said it is carefully reviewing FDA’s feedback and promised a full response to the FDA letter. “We take any potential issue with our products very seriously and are cooperating fully with FDA on this matter,” said Richard Byrd, worldwide president of BD Preanalytical Systems, in a statement. “After the FDA inspection in July, we took prompt action that we believed fully addressed the agency’s inspectional observations.”