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The US Food and Drug Administration (FDA) issued an alert to advise that people should not use the ACON Laboratories test “Flowflex SARS-CoV-2 Antigen Rapid Test (Self Testing” that is packaged in a dark blue box (see above).
Officials said that the test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and the agency is concerned about the risk of false results from those using it.
The unauthorized test uses a nasal swab sample to detect antigens from SARS-CoV-2, the virus that causes COVID-19, they said. The unauthorized test has a dark blue box with white lettering and symbols in the lower right corner of the box, including the letters “CE.”
FDA officials noted that the ACON Laboratories Flowflex COVID-19 Antigen Home Test was authorized by the agency in October 2021 and is not the subject of a safety alert.
The FDA has not received any reports of injuries, adverse health effects, or death associated with the use of the Flowflex SARS-CoV-2 Antigen Rapid Test.
According to the FDA, anyone who believes they were tested with the ACON Flowflex SARS-CoV-2 Antigen Rapid Test and has concerns about the results should consult their healthcare provider.
“The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The FDA is working with ACON Laboratories, Inc. to resolve this safety issue,” officials said.
"ACON Laboratories, Inc. has initiated a recall for all unauthorized Flowflex SARS-CoV-2 Antigen Rapid Tests (Self-Testing) tests that were distributed in the US.”
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