(WWTI) — The Food and Drug Administration has issued a recall on the “Flowflex™ SARS-CoV-2 Antigen Rapid Test.” According to the FDA, this test was first recalled in early January by ACON Laboratories Inc. as it is the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test.”

ACON identified the U.S Distribution the “Flowflex™ SARS-CoV-2 Antigen Rapid Test” to be unauthorized, adultered, and a misbranded counterfeit product.

The recall, officially published by the FDA on March 11, stated that the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing),” cannot be legally imported, distributed or used in the U.S. market as it has not been approved, cleared or authorized by the FDA.

Additionally, the “Flowflex COVID-19 Antigen Home Test” cannot be legally imported, distributed, or used in the European market as it is not CE marked. Below are images of the recalled product compared to the FDA authorized Antigen test.

The FDA further warned that COVID-19 Antigen tests that lack FDA approval, clearance or authorization can pose significant risks as they may lead to inaccurate test results. This can include both false-negative or false-positive results, which can lead to a delayed diagnosis or improper treatment of SARS-CoV-2.

Those who have received the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” with the blue box in the U.S. market, were directed to stop using this product and dispose of it. ACON is working with the FDA and other law enforcement agencies to ensure that only the FDA authorized “Flowflex COVID-19 Antigen Home Test” is distributed in the U.S.

Any distribution of the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” should be reported immediately.