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.
FDA Recalls 284,000+ COVID-19 Tests
The tests are approved for use in Canada and the E.U., but not the United States.
Feb 11, 2022
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