The FDA Recalls Two At-Home Covid Tests, Says They Could Give False Results
“The FDA is concerned about the potentially higher risk of false results.”
The U.S. Food and Drug Administration (FDA) wants people to steer clear of Empowered Diagnostics Covid-19 tests as it’s concerned they could give false results. The brand’s CovClear Covid-19 Rapid Antigen Test and ImmunoPass Covid-19 Neutralizing Antibody Rapid Test have not been not authorized by the FDA but were distributed with labeling that indicated they were, the agency said on Friday. The tests, which were manufactured in the United States, have been recalled.
“The FDA is concerned about the potentially higher risk of false results when using unauthorized tests,” the agency said in the recall alert, noting that neither the antibody nor rapid test has been “authorized, cleared, or approved for distribution or use in the United States by the FDA.”
As of December, Empowered Diagnostics’ at-home rapid test is authorized in Canada. The company also states on its website that it’s authorized for use, or “has CE marking,” in the European Union. At-home rapid tests are used to diagnose a current infection, while an antibody test can detect antibodies from a prior or recent Covid-19 infection.
The recalled Covid tests — 284,575 antigen tests and about 2,100 antibody tests — were distributed in the United States between Jan. 1, 2021 to Nov. 11, 2021, according to the FDA. Empowered Diagnostics announced a voluntary recall back in December, alerting customers via email to stop using the test and to contact the company for a refund.
If you took an at-home rapid Empowered Diagnostics test and are concerned about your results, the FDA suggests talking to your health care provider and possibly retesting.
The FDA also recently issued a recall on antibody and antigen tests produced by LuSys Laboratories. In a warning to consumers issued on Jan. 11, the FDA said that the performance of the LuSys Laboratories Covid-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories Covid-19 IgG/IgM Antibody Test “has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests.”
Wondering if your at-home Covid test is approved by the FDA? You can find a full list here. In need of a test? You can request four free tests, per residential address, from the COVIDTests.gov and get eight tests per month covered by your insurance.