On March 1, 2022, The Food and Drug Administration alerted health care providers and the public to three COVID-19 antigen tests that are not authorized or approved for distribution or use in the United States. Due to the potential for false results, FDA said providers should consider retesting patients with an authorized test if these tests were performed less than two weeks ago and they suspect an inaccurate result. (Source: American Hospital Association )
Because the tests have not been authorized, cleared or approved by the FDA for distribution or use in the United States, the FDA is concerned about the risk of false results.
Tests included in the alert:
- Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging.
- SD Biosensor STANDARD Q COVID-19 Ag Home Test that is packaged in a white and magenta box
- ACON Laboratories “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)", packaged in a dark blue box
If an antigen test was performed less than two weeks ago using one of these tests, the FDA advises to 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.
The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the unauthorized tests. Click here for full FDA communication