(WKBN) — The U.S. Food and Drug Administration (FDA) issued a safety communication warning people not to use some brands of home COVID-19 tests.
The SD Biosensor STANDARD Q COVID-19 Ag Home Test, packaged in a white and magenta box (see above image), has not been authorized, cleared or approved by the FDA for distribution or use in the United States.
The Celltrion DiaTrust COVID-19 Ag Rapid Test, packaged in green and white packaging (see image below), has also not been authorized, cleared or approved by the FDA for distribution or use in the United States.
The FDA also warned against using ACON Laboratories test named “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” that is packaged in a dark blue box (see image below).
The FDA is concerned about the risk of false results when using these unauthorized tests.
If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.