Last week FDA issued a warning letter to Becton Dickinson after finding several violations of law following an agency inspection of the company’s facility in New Jersey. The 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 the FDA within the required timeframe,” according an FDA release. The agency stated that this change could affect the safety and effectiveness of the devices. BD also did not evaluate and investigate a complaint related to variability in test results in which specific Vacutainer blood collection tubes were used with Magellan Diagnostics’ LeadCare test systems.
“Our inspection showed that BD violated the law by making a significant change to certain devices the company manufactures without notifying the FDA and failing to follow good manufacturing practice requirements. We are continuing to aggressively investigate this issue, including whether the use of BD tubes led to inaccurate lead test results.” –Donald St. Pierre, Office of In Vitro Diagnostics and Radiological Health and CDRH
Becton Dickinson has been the subject of an FDA investigation since last year when FDA stated that the Magellan LeadCare test systems might generate inaccurate results. In May 2017, the agency recommended that labs and healthcare professionals follow FDA’s instructions related to retesting using blood drawn from a finger or heel stick. Magellan told its customers that the inaccurate results could have been related to the composition of the rubber stoppers of specific BD collection tubes, but FDA couldn’t verify these findings, which lead to its own investigation into the problem. This investigation included an inspection of the BD facility.
BD must notify FDA of what it is doing to address the violations and how it will prevent them from happening again by February 1.