The Food and Drug Administration (FDA) has cleared ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, the first over-the-counter (OTC) antigen test. Previously, the test was authorized for ...

The Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) kit isn’t authorized for sale in the United States. FDA ACON Laboratories wants U.S. consumers to use its “Flowflex COVID-19 Antigen Home Test ...

A coronavirus antigen test has been recalled after officials discovered that it was a counterfeit and not approved by the Food and Drug Administration (FDA) for use in the United States. ACON ...

An example shared by the FDA comparing a counterfeit Flowflex COVID-19 Antigen Home Test with a real, FDA-authorized one. Food and Drug Administration Keep an eye out for counterfeit at-home COVID-19 ...

According to the agency, an extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized. For more information ...