The tests are not authorized for sale in the U.S. They have only been cleared for Europe and other markets.
The Flowflex SARS-CoV-2 Antigen Rapid Tests “cannot be legally imported, distributed or used in the U.S. as it has not been approved, cleared, or authorized by the FDA.” The recall does not impact a similarly branded test manufactured by ACON Labratories, Inc. — the “Flowflex COVID-19 Antigen Home Test” — which has been approved for use in the U.S.If you have the recalled tests which come in a blue box, you are being told to not use them and dispose of them. The approved test comes in a primarily white box.
Why would they be allowed in only some countries?
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