The Food and Drug Administration has announced another recall of COVID-19 tests.
The FDA announced the recall of Flowflex SARS-CoV-2 Antigen Rapid Tests (Self-Testing).
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 (Self-Testing) “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.
The recalled tests could have false results, either positive or negative, the FDA said.
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.
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