The U.S. Food and Drug Administration (FDA) issued a Class I recall, the most serious type of recall, for Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test
The FDA also warned that these tests were distributed with labeling indicating they are authorized by the Adminsitration, 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, which has led to Empowered Diagnostics to recalling both tests.
The FDA has asked test users and caregivers to talk to their healthcare provider if they were tested with the CovClear COVID-19 Rapid Antigen Test or ImmunoPass COVID-19 Neutralizing Antibody Rapid Test and have concerns about the results.
The FDA also suggests healthcare providers and testing program organizers to consider retesting patients using an FDA authorized SARS-CoV-2 antibody test if they suspect a recent or prior COVID-19 infection.
The CovClear COVID-19 Rapid Antigen Test uses a nasal swab sample to detect proteins from SARS-CoV-2, while the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test uses a fingerstick blood sample to detect antibodies produced by a person’s immune system in response to SARS-CoV-2. If a test detects antibodies, it means the person may previously have been infected with the SARS-CoV-2 virus.
The FDA is working with Empowered Diagnostics to resolve issues of the recall. The FDA will continue to keep the public informed of significant new information.