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.
