On December 27, 2021, the Food and Drug Administration issued a recall for “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)," a product sold at an unknown number of pharmacies and distributed by local health officials. The easy-to-use at-home test has been approved in European and other markets, but did not receive the required emergency use authorization by the FDA.
The recall of the test, which the government estimates has 200,000 in U.S. circulation, may confuse consumers between two Flowflex branded antigen tests.
Packaged in a white box and given the proper emergency use authorization, the "Flowflex™ COVID-19 Antigen Home Test" is approved in the U.S.
ACON released a side-by-side comparison of the two products hoping to help U.S. consumers differentiate between the recalled test and the one cleared for emergency use.
The manufacturer of the Flowflex tests, ACON Laboratories, said it was aware of the "unauthorized, adulterated and misbranded counterfeit product" and issued a recall order on Jan. 9.
"COVID-19 Antigen tests in the U.S. market that lack FDA approval, clearance, or authorization can pose significant risk since they may lead to inaccurate test results, including false negative or false positive test results," a statement from the manufacturer said this week.
Consumers in possession of the unauthorized test are encouraged by the FDA to dispose of the product and if already used to detect a possible COVID infection, seek an additional test from a federally approved provider.
At Nexgen Health Group, Genuine FlowFlex COVID-19 Test Kits can be purchased.