Acon Laboratories has recalled unauthorized and misbranded counterfeit COVID-19 at-home testing kits.
The manufacturer of the "Flowflex COVID-19 antigen home test, which is approved for emergency use authorization in the U.S., said it discovered counterfeit Flowflex SARS-CoV-2 antigen rapid test (self-testing) kits being distributed across the nation. The product is only authorized for sale in Europe and other markets, according to a March 11 FDA recall notice.
The notice said the manufacturer has not received any reports of adverse events related to the products and is issuing the recall out of an abundance of caution.