(WKBN) — The U.S. Food and Drug Administration (FDA) issued a safety warning against using some brands of home COVID-19 tests.
The FDA said there is a risk of false results — either positive or negative for COVID-19 — when using these tests, which have not been “authorized, cleared or approved by the FDA for distribution or use in the United States.”
One is the SD Biosensor STANDARD Q COVID-19 Ag Home Test, packaged in a white and magenta box. The test is administered using a nasal swab sample.
Another is the Celltrion DiaTrust COVID-19 Ag Rapid Test, packaged in green and white packaging. The test also uses a nasal swab sample.
The FDA also warned against using the ACON Laboratories test named “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing),” which is packaged in a dark blue box. The test uses a nasal swab sample.
Recalls have been initiated for the unauthorized SD Biosensor and Flowflex tests. A recall has been issued for the unauthorized DiaTrust test.
The FDA has received no reports of injuries, adverse health consequences, or death associated with use of the affected tests.
The FDA is urging users of any of the tests to talk to their health care providers if they have concerns about the results. The agency also advised that health care providers and testing organizers consider retesting their patients if the above tests were administered within less than two weeks and they suspect results that are inaccurate.
Retesting should be done with an FDA authorized SARS-CoV-2 diagnostic test.
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.
