FDA Class I Recall: Empowered Diagnostics COVID-19 tests

Feb. 2, 2022

The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.

These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the potentially higher risk of false results when using unauthorized tests.

Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, and the FDA has identified this issue as a Class I recall, the most serious type of recall.  

Recommendations:

  • Do not use the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.
  •  CovClear COVID-19 Rapid Antigen Test
  • Test users and caregivers: Talk to your healthcare provider if you were tested with the CovClear COVID-19 Rapid Antigen Test and you have concerns about your test results. 
  • Healthcare providers and testing program organizers: If the antigen test was given less than two weeks ago, consider retesting your patients using an FDA authorized SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest. 

FDA release

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