FDA warns of possible false results from unauthorized COVID-19 tests

The Hill
·2 min read


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.

The Celltrion tests that are being recalled are the European version of the DiaTrust COVID-19 Ag Rapid Test, according to the company, and were illegally distributed throughout the U.S. The European version of the test differs visually from the U.S.-authorized version, with a green and white package that can be seen on the FDA's website.

SD Biosensor also has a test that has been approved for use in the U.S., the COVID-19 At-Home Test. This product is distributed by Roche and can still be used by patients. ACON Laboratories' Flowflex COVID-19 Antigen Home Test was also authorized by the FDA in October.

In a statement, ACON Laboratories called the unauthorized tests an "adulterated and misbranded counterfeit product." Like Celltrion's test, ACON Laboratories said the test being recalled was only authorized for use in Europe and other markets outside the U.S.

The unauthorized version of ACON Laboratories' product differs visually, features mostly dark blue packaging while the version authorized by the FDA is mostly white with light blue details.