The FDA issued an urgent warning.
on the U.S. Food & Drug Administration website on Mar. 11, these products are selling with the trade name Flowflex SARS-CoV-2 Antigen Rapid Test .ACON Laboratories is not importing tests by this name into the U.S. as it is only authorized for sale in Europe and other markets. The FDA's notice serves as public announcement that this CE-marked product is being recalled from the U.S. market. It states that the product"cannot be legally imported, distributed, or used in the U.S.
"Similarly, the Flowflex COVID-19 Antigen Home Test cannot be legally imported, distributed, or used in the European market as it is not CE marked. These two products have been authorized by the U.S. FDA and registered under CE Mark authorities separately under different product registration requirements, and therefore the recall doesn't impact the distribution and use of the CE-marked Flowflex SARS-CoV-2 Antigen Rapid Test Self-Testing kits in Europe and other markets outside of the U.
France Dernières Nouvelles, France Actualités
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