US FDA: Bad Lead Test Results Tied To Test-Tube Stopper Chemical
An investigation by FDA and BD has concluded that a chemical used in some test-tube stoppers is the reason for false results on some blood-based lead tests from Magellan Diagnostics.
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Several additional batches of Magellan’s LeadCare II tests are being recalled as efforts to address the root cause continue.
The agency letter cites quality systems, Medical Device Reporting and device clearance concerns. It stems from an ongoing investigation into lead tests distributed by Magellan Biosciences that sometimes give faulty results.
Common blood tests for lead poisoning manufactured by Magellan Diagnostics could give false low results if used with venous blood, FDA warned. About 8 million of the tests have been performed since 2014.