Becton Dickinson blood tubes under investigation in FDA probe of faulty lead tests

(Reuters) – Blood collection tubes made by Becton Dickinson & Co. (NYSE:BDX) 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.”
The post Becton Dickinson blood tubes under investigation in FDA probe of faulty lead tests appeared first on MassDevice.

Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: MassDevice Tags: Blood Management Diagnostics Food & Drug Administration (FDA) bectondickinson Source Type: news