The U.S. Food and Drug Administration (FDA) recently issued three safety communications advising people to avoid using certain COVID-19 tests.
The three tests the FDA is advising people to not use include certain Celltrion DiaTrust COVID-19 tests; the SD Biosensor STANDARD Q COVID-19 Ag home tests; and certain ACON Flowflex COVID-19 tests.
None of these tests have been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA says it is concerned about the risk of false results when using these unauthorized tests.
The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the unauthorized tests.
FDA Recommendations for these COVID Tests
- For test users and caregivers: Talk to your healthcare provider if you think you were tested with any one of these tests and you have concerns about the test results.
- Healthcare providers and testing program organizers: If an antigen test was performed less than two weeks ago using any one of these tests consider retesting 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 regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The FDA is working to resolve these safety issues.
The FDA will continue to keep the public informed of significant new information.
