August 17, 2017 / 11:52 PM / a year ago

FDA probes possible Becton Dickinson link to faulty lead tests (Aug. 17)

(The August 17 story has been updated with a correct headline and first paragraph to show the FDA is still investigating blood tubes from Becton Dickinson and the tubes have not been ruled out yet)

(Reuters) - Blood collection tubes made by Becton Dickinson & Co that were used in conjunction with Magellan Diagnostics’ lead-testing devices are still being investigated as a potential cause of inaccurate lead test results.

The FDA in May had warned that Magellan’s LeadCare test systems performed on blood samples might provide inaccurate results.

Prior to that, Magellan, a unit of Meridian Bioscience Inc, had said that inaccurate blood test results could potentially be related to a change in the composition of the tops of certain blood collection tubes made by Becton Dickinson.

Magellan’s devices are the only lead-testing products cleared by the FDA and account for about half of all lead tests in the United States.

The FDA on Thursday said that it had found several potential violations at Becton Dickinson’s facility, “however, at this time, we have not determined that the BD tubes or any other brand of tube is linked to the cause of the inaccurate lead test results. We are continuing to aggressively investigate the matter.”

Reporting by Anirban Paul in Bengaluru; Editing by Leslie Adler

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