After launching an investigation into the root cause of false lead test results from four of Magellan Diagnostics' LeadCare testing systems last May, the US Food and Drug Administration (FDA) on Thursday warned Becton Dickinson (BD) for failing to submit a new 510(k) for changes to its blood collection tubes.
At the outset of the investigation, Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren said the agency was working to determine the root cause of the inaccurate test results, but was still not certain whether the issues were due to differences in how blood samples are collected, the tubes used to hold the blood or a change in how the samples are processed.
As part of the investigation, FDA inspected BD's Franklin Lakes, New Jersey facility where it makes its Vacutainer blood collection tubes over the course of three weeks in May and June.
"Our inspection showed that BD violated the law by making a significant change to certain devices … without notifying the FDA and failing to follow good manufacturing practice requirements," said Donald St. Pierre, deputy director of new product evaluation at CDRH. FDA also said that BD failed to investigate a complaint from Magellan from 2015 involving "observed negative bias" in test results with Magellan's LeadCare test systems when using the Vacutainer tubes.
"Your firm did not enter this information into its complaint system, evaluate the complaint to determine if it represents an MDR [medical device reporting] reportable event, or initiate an investigation of the complaint," FDA writes.
While FDA said that the changes made to the composition of the rubber stoppers used with the Vacutainer tubes could create new interferences with laboratory tests and result in biased results, the agency said it is not sure whether the change caused the inaccurate LeadCare test results.
In a statement on Friday, Richard Byrd, BD's president of preanalytical systems, said the company is cooperating with FDA and that he believes the company fully addressed the agency's inspection observations.
Update on BD Syringes
FDA on Friday also announced that BD has stopped using rubber stopper material in its syringes that was found to reduce drug potency.
In September 2015, FDA warned healthcare professionals against using BD's general use syringes with compounded or repackaged drugs stored in the syringes due to the potential of the drugs interacting with the rubber stopper in the syringe.
While FDA cleared the syringes for general purpose fluid aspiration and injection, they were not cleared for use as closed container storage systems for drugs.
Now, FDA said BD stopped using the rubber stopper material linked to the loss of drug potency, and has reverted to using a rubber stopper used in other syringes.
Healthcare professionals are requested to contact BD to determine whether specific lots of the syringes contain the new stoppers.
Warning Letter, FDA Statement, BD Statement, Safety Communication