FDA alerts labs to false positives with BD coronavirus reagents

2020 07 06 20 11 8873 Fail Pass 400

The U.S. Food and Drug Administration (FDA) has alerted labs and healthcare providers to the risk of false positives with SARS-CoV-2 reagents manufactured by Becton Dickinson (BD).

In one study conducted by the company, BD SARS-CoV-2 reagents, which are used with the BD Max system, showed a 3% rate of false positive results, the FDA noted in a statement. The FDA is advising labs and healthcare providers to consider confirming positive results with an alternative authorized test and issued a reminder to notify the agency of problems with COVID-19 tests.

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