(CMR) A common rapid at-home COVID test was recalled by the FDA last month over concerns the antigen test hasn't received proper U.S. authorization.
The Food and Drug Administration issued a recall for popular Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) at the end of December stating that the “devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA)”. Despite the FDA's position, the test approved in European and other markets are widely used in the Cayman Islands.
ACOB Laboratories, who manufacture the Flowflex test, said it was aware of the “unauthorized, adulterated and misbranded counterfeit product having the trade name ‘Flowflex SARS-CoV-2 Antigen Rapid Test (Self Testing).’”
The company said it is not importing the test into the U.S. because it is only authorized in Europe and some other markets. The company also recalled the product from the U.S. shortly after the FDA notice.
The recall will impact some 200,000 units in the US market and should not be confused with a similar Flowflex™ COVID-19 Antigen Home Test” which is approved in the U.S.
ACON put out photos of the two. The approved home testing kit is pictured on the right in the white box.
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.