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NEW YORK ─ The US Food and Drug Administration on Monday issued a warning letter to clinical laboratory staff and healthcare providers to alert them about an increased risk of false-positive results from Becton Dickinson's BD SARS-CoV-2 reagents for its BD Max System test.

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.