FDA Warns Against Use of Certain COVID-19 Tests
3/1/22 — The FDA is warning people not to use certain COVID-19 rapid antigen tests that have not been authorized, cleared, or approved by the FDA for distribution or use in the United States. These tests include, Celltrion USA Inc. DiaTrust COVID-19 Ag Rapid Tests the SD Biosensor STANDARD Q COVID-19 Ag Home Test, and the ACON Flowflex SARS-CoV-2 Antigen Rapid Test. The FDA is concerned about the risk of false results when using these unauthorized tests.