FDA: Class I recall of Empowered Diagnostics COVID-19 tests

Editor's Note

The Food and Drug Administration (FDA) on January 28 identified the recall by Empowered Diagnostics (Pompano Beach, Florida) of its CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test as Class I, the most serious.

Empowered Diagnostics distributed these tests with labeling indicating they were authorized by the FDA, but neither test has been authorized, cleared, or approved for distribution or use in the US by the FDA.

The FDA says it is concerned about the higher risk of false results when using unauthorized tests.

Distribution dates were January 1, 2021, to November 11, 2021.