FDA Warns BD Over Changes Made to Blood Collection Tubes in Lead Testing Investigation

After examining the cause of the faulty lead test of four of Magellan Diagnostics LeadCare test systems last May, the Food and Drug Administration (FDA) warned Becton Dickinson (BD) on Thursday that it has not submitted a new lead test. 510 (k) for changes in his blood collection tubes.

At the beginning of the study, Jeffrey Shuren, director of the Center for Apparatus and Radiological Health (CDRH), said that the agency tried to determine the cause of the inaccurate test results, but still did not know these problems because of differences in blood. samples are collected, tubes are used to hold blood or a change in the way samples are processed.

As part of the investigation, the FDA inspected BD facilities in Franklin Lakes, New Jersey, where it produces Vacutainer blood collection tubes for three weeks in May and June.

"Our inspection has shown that BD has violated the law by making major changes to certain devices ... without notifying the FDA and not following good manufacturing practices," said Donald St. Pierre, Deputy Director of Evaluation. new products on CDRH. The FDA also stated that BD had not investigated a 2015 Magellan complaint regarding "observed negative bias" in test results with Magellan's LeadCare test systems when using Vacutainer tubes.

"Your company did not record this information in the complaints system, did not evaluate the complaint to determine whether this was a reportable event, or started an investigation into the complaint," the FDA wrote.

Although the FDA has stated that changes in the composition of rubber stoppers used with Vacutainer tubes may cause new interference with laboratory tests and lead to biased results, the agency said it was uncertain.

In a statement released on Friday, Richard Byrd, president of BD's pre-analytical systems, said the company was working with the FDA and thought the company was responding fully to the agency's inspection observations.

Update on BD spraying

On Friday, the FDA also announced that BD has stopped using rubber stoppers in its syringes, which reduces the power of the drug.

In September 2015, the FDA warned health professionals against the use of BD general-purpose syringes with compounded or reconditioned drugs stored in syringes due to the potential of drugs that interact with the rubber stopper in the syringe.

Although the FDA has approved approved syringes for general aspiration and injection of fluids, they are not authorized to be used as closed container storage systems for pharmaceuticals.

Now the FDA has declared that BD has stopped the rubber stopping material with regard to the power loss of the medicine and has returned with a rubber stopper used in other syringes.

Healthcare professionals should contact BD to determine if specific batches of syringes contain the new caps.