Do Not Use Certain ACON Flowflex COVID-19 Tests

U.S. Food and Drug Administration sent this bulletin at 03/01/2022 03:15 PM EST

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CDRH Medical Device Safety Communication

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Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication 

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication warning people not to use the ACON Laboratories test named “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).” This test is packaged in a dark blue box (see image below) and has not been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) Packaging

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This safety communication provides: 

  • Recommendations for test users, caregivers, health care personnel, and testing program organizers.
  • Details on the issue and the FDA’s actions to address the issue.
  • Instructions for reporting problems with tests to the FDA. 

Questions? 

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).