Home > Articles > FDA Warns Becton Dickinson (BD) & Company of Significant Violations as Part of Ongoing Investigation into Lead Testing Issues

FDA Warns Becton Dickinson (BD) & Company of Significant Violations as Part of Ongoing Investigation into Lead Testing Issues

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January 1114th 2018

The Food and Drug Administration 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. For full text,

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm592163.htm

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