FDA Cautions Against Using Empowered Diagnostics COVID-19 Tests

The US FDA is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, according to an agency alert.

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.  

CovClear COVID-19 Rapid Antigen Test

• Test users and caregivers: Talk to your health care 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. 
• Report any problems you experience with the CovClear COVID-19 Rapid Antigen Test to the FDA, including suspected false results.

ImmunoPass COVID-19 Neutralizing Antibody Rapid Test

• Test users and caregivers: Talk to your health care provider if you were tested with the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test and you have concerns about your test results.
• Healthcare providers and testing program organizers: Consider retesting your patients using an FDA authorized SARS-CoV-2 antibody test if you suspect a recent or prior COVID-19 infection.
• Report any problems you experience with the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test to the FDA, including suspected false results.

If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form. 

Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.