FDA WARNS OF POSSIBLE FALSE RESULTS FROM UNAUTHORIZED COVID-19 TESTS

The Food and Drug Administration (FDA) on Tuesday named three unauthorized rapid COVID-19 tests that it says people should not use due to the risk of false results.

The FDA instructed people to not use the Celltrion DiaTrust COVID-19 Ag Rapid Test, the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test and the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).

“The FDA is concerned about the risk of false results when using this unauthorized test,” said the agency.

All three tests work through the use of a nasal swab. The agency has recommended that healthcare providers and  testing program organizers retest patients who have used any of these unauthorized tests less than two weeks ago.

All three companies have issued recalls for these tests. At least 162,000 unauthorized tests from Celltrion were distributed in the U.S. Two other COVID-19 tests from Celltrion have been authorized by the FDA: the DiaTrust COVID-19 Ag Home Test and the DiaTrust COVID-19 Ag Rapid Test.