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

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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 Rapid Test (Self-Testing)” into the U.S. as it is only authorized for sale in Europe and other markets, under the CE mark. This press release serves as public announcement that this CE marked product is being recalled from the U.S. market. 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. The “Flowflex COVID-19 Antigen Home Test” cannot be legally imported, distributed, or used in the European market as it is not CE marked.