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FDAJuly 27, 2021device

Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.

What to do

FDA enforcement status: Terminated

Brands named

versea diagnosticsversea

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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