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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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

Update: The U.S. Food and Drug Administration (FDA) updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in dark blue packaging is a product of ACON Biotech (Hangzhou) Co., Ltd.

The FDA issued a safety communication warning people not to use the ACON Biotech 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.

Front of Box Label                                                  Back of Box Label

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).