The U.S. Food and Drug Administration today 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. Continue reading…
