FDA warns against using Empowered Diagnostics COVID-19 tests

The Food and Drug Administration (FDA) warned people to stop using two tests produced by Empowered Diagnostics: CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with false labeling indicating they were authorized by the FDA. The agency did not authorize, clear or approve the tests for distribution or use in the United States and expressed concern about the potentially higher risk of false results when using unauthorized tests. Empowered Diagnostics is recalling both tests. (FDA safety communication, 1/28/22)