Month: February 2022

UPDATED STATEMENT ON THE OMICRON VARIANT

ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants, including the Omicron variant. We are pleased to report that an independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has indicated that the Flowflex™ COVID-19 Antigen Home Test does detect the Omicron variant in live clinical samples. ACON will continue to …

UPDATED STATEMENT ON THE OMICRON VARIANT Read More »

ACON Laboratories Issues a Recall of non-EUA Authorized “Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing)” Tests From the U.S. Market

SAN DIEGO, CA, January 9, 2022 – ACON Laboratories, Inc. (“ACON Laboratories”), the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test” (FDA Emergency Use Authorization EUA210494), has identified the U.S. distribution of unauthorized, adulterated and misbranded counterfeit product having the trade name “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).” ACON Laboratories is not importing the “Flowflex SARS-CoV-2 Antigen …

ACON Laboratories Issues a Recall of non-EUA Authorized “Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing)” Tests From the U.S. Market Read More »