People should stop using the Empowered Diagnostics CovClear COVID-19 rapid antigen test and ImmunoPass COVID-19 neutralizing antibody rapid test, the U.S. Food and Drug Administration (FDA) said in an email on January 28.
The tests were distributed with labeling claiming they are authorized by the FDA, but in fact, neither one has been authorized, cleared, or approved by the FDA for distribution or use in the U.S., the agency said in its email.
The tests have been recalled by the company, and the recall has been identified as a class I recall, the most serious by the agency.
The CovClear test uses a nasal swab sample, and the ImmunoPass test uses a fingerstick blood sample. The agency said it is concerned about a potentially higher risk of false results with the unauthorized tests.
