![]() market as it has not been approved, cleared, or authorized by the FDA. The “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” cannot be legally imported, distributed, or used in the U.S. This press release serves as public announcement that this CE marked product is being recalled from the U.S. as it is only authorized for sale in Europe and other markets, under the CE mark. See More the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” into 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. (“ACON Laboratories”), the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test” (FDA Emergency Use Authorization EUA210494), has identified the U.S.
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