Updated Jan. 12 to include a statement from BD.
The inspection, which was done as part of the agency’s ongoing investigation into the cause of inaccurate blood lead tests linked to Magellen Diagnostics, showed that BD marketed a significantly-modified version of its Vacutainer blood collection tube without FDA clearance or approval.
The regulatory body also found that the company failed to investigate a complaint regarding the variable test results seen when particular Vacutainer tubes were used with Magellan’s LeadCare tests.
“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,” Donald St. Pierre from the Office of In Vitro Diagnostics and Radiological Health and the FDA’s Center for Devices and Radiological Health said in prepared remarks.
“We are continuing to aggressively investigate this issue, including whether the use of BD tubes led to inaccurate lead test results.”
In May last year, the FDA warned that Magellan’s LeadCare tests, when used with blood drawn from the vein, may give inaccurate results. Magellan has also reportedly told its customers that the inaccurate results may be linked to the components of the rubber stopper used in BD’s blood collection tubes. The diagnostics company has advised customers not to use BD’s Vacutainer tubes with Magellan’s blood lead tests.
But the FDA said today that it does not have any evidence showing that other blood tests are affected when BD tubes are used and the product is still on the market. The FDA is in talks with BD about the investigation and the company has until Feb. 1 to tell the agency how it will address the violations discovered in the inspection of its N.J.-based facility.
The worldwide president of BD’s preanalytical systems business, Richard Byrd, issued a statement in response to the FDA’s warning.
“Ensuring the safety and quality of our products is our top priority at BD, and we are dedicated to maintaining a robust quality system to fulfill this commitment. We take any potential issue with our products very seriously and are cooperating fully with FDA on this matter. After the FDA inspection in July, we took prompt action that we believed fully addressed the agency’s inspectional observations. We are carefully reviewing the agency’s feedback outlined in yesterday’s letter with the highest sense of urgency, and we will provide a full response to FDA on or before their Feb. 1 deadline. We will continue to demonstrate our commitment to serving the public health as well as meeting FDA’s expectations,” Byrd said.