U.S. Food and Drug Administration01.12.18
The U.S. 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.
“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,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health. “We are continuing to aggressively investigate this issue, including whether the use of BD tubes led to inaccurate lead test results.”
In May 2017, the FDA advised Americans that Magellan's LeadCare test systems performed on blood drawn from the vein (venous) may provide inaccurate results and recommended that laboratories and health care professionals follow the FDA's recommendations concerning retesting using blood drawn from a finger or heel stick. Prior to this warning, Magellan informed its customers that the inaccurate results may potentially be related to the composition of the rubber stopper of certain BD blood collection tubes—specifically, tubes with lavender- or tan-colored tops—and advised customers to no longer use these types of tubes with Magellan’s blood lead tests. The FDA could not verify these findings at the time and launched its own investigation into the issue to determine the cause of the inaccurate results, which included an inspection of BD's Franklin Lakes, N.J. facility.
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. We are actively communicating with BD about their investigation into this matter and will continue to keep the public informed.
During the inspection, the FDA’s investigators found evidence of numerous violations, including BD’s failure to notify the FDA about a significant change that the company made to the rubber stoppers for certain BD Vacutainer blood collection tubes that could significantly affect the safety or effectiveness of these devices. The inspection also revealed evidence that the company failed to comply with the good manufacturing practice requirements of FDA’s Quality System regulation. For example, BD was cited for violations of device design validation requirements and for failure to adequately review, evaluate, and investigate complaints.
BD has until Feb. 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.
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.
“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,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health. “We are continuing to aggressively investigate this issue, including whether the use of BD tubes led to inaccurate lead test results.”
In May 2017, the FDA advised Americans that Magellan's LeadCare test systems performed on blood drawn from the vein (venous) may provide inaccurate results and recommended that laboratories and health care professionals follow the FDA's recommendations concerning retesting using blood drawn from a finger or heel stick. Prior to this warning, Magellan informed its customers that the inaccurate results may potentially be related to the composition of the rubber stopper of certain BD blood collection tubes—specifically, tubes with lavender- or tan-colored tops—and advised customers to no longer use these types of tubes with Magellan’s blood lead tests. The FDA could not verify these findings at the time and launched its own investigation into the issue to determine the cause of the inaccurate results, which included an inspection of BD's Franklin Lakes, N.J. facility.
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. We are actively communicating with BD about their investigation into this matter and will continue to keep the public informed.
During the inspection, the FDA’s investigators found evidence of numerous violations, including BD’s failure to notify the FDA about a significant change that the company made to the rubber stoppers for certain BD Vacutainer blood collection tubes that could significantly affect the safety or effectiveness of these devices. The inspection also revealed evidence that the company failed to comply with the good manufacturing practice requirements of FDA’s Quality System regulation. For example, BD was cited for violations of device design validation requirements and for failure to adequately review, evaluate, and investigate complaints.
BD has until Feb. 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.
