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FDA warns against use of certain COVID-19 rapid tests - ABC7 News

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The US Food and Drug Administration is telling people not to use certain ACON Laboratories COVID-19 tests.

The Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) kits in the dark blue packaging are not authorized, cleared or approved by the FDA for distribution or use in the United States, the agency said in a release on Tuesday.

The warning was issued because FDA officials are concerned about the risk of false results from the testing kits.

There have been no reports of injuries, adverse health consequences or death associated with the ACON Flowflex COVID-19 tests.

If you have concerns about test results from one of the ACON tests, speak with your health care provider.

The ACON Laboratories Flowflex COVID-19 Antigen Home Test is still clear by the FDA for use.

ACON Laboratories has issued a recall for the unauthorized tests.

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FDA warns against use of certain COVID-19 rapid tests - ABC7 News
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