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FDA Recalls 284,000+ COVID-19 Tests

The tests are approved for use in Canada and the E.U., but not the United States.

A recent FIERCE Biotech article noted the Class I recall of Empowered Diagnostics unauthorized COVID tests. The Florida-based testmaker was forced to pull 284,575 CovClear rapid antigen tests and 2,100 ImmunoPass rapid antibody tests from shelves that don’t meet the FDA’s standards of consistency and quality.

The CovClear test is a nasal swab that diagnoses active cases of COVID-19 in about 20 minutes. It’s authorized in Canada and the E.U. for at-home and point-of-care use respectively, but has yet to receive FDA approval. The ImmunoPass test collects a fingerstick blood sample and detects antibodies, indicating a previous case of the virus, in just 10 minutes. 

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