(WWTI) – The Food and Drug Administration has issued a revocation of 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 US distribution “Flowflex ™ SARS-CoV-2 Antigen Rapid Test” as unauthorized, counterfeit, and mislabeled.
The recall, officially announced by the FDA on March 11, stated that the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” could not be legally imported, distributed or used in the US market as it has not been approved, approved or approved by the FDA.
In addition, the “Flowflex COVID-19 Antigen Home Test” cannot be legally imported, distributed or used on 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, approval, or approval can pose significant risks as they can lead to inaccurate test results. This can include both false-negative or false-positive results, which can lead to a delayed diagnosis or incorrect 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 US market were asked to stop using this product and discard it. ACON cooperates with FDA and other law enforcement agencies to ensure that only the FDA-authorized “Flowflex COVID-19 Antigen Home Test” is distributed in the United States
Any distribution of the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Test)” must be reported immediately.