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March 11, 2022, Update: The FDA updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Tests (Self-Testing) in dark blue packaging are a product of ACON Biotech (Hangzhou) Co., Ltd.

The U.S. Food and Drug Administration (FDA) is warning people not to use certain ACON COVID-19 tests, a product of ACON Biotech (Hangzhou) Co., Ltd. People should not use the ACON Biotech test named “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” that is packaged in a dark blue box (see images below). This test 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. 

The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).

If you have an ACON Flowflex COVID-19 test, compare the packaging to the image above. Do not use the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in the dark blue packaging, as shown above.

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. 

ACON Laboratories, Inc. has initiated a recall for all unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Tests (Self-Testing) tests that were distributed in the U.S.

The FDA will continue to keep the public informed of significant new information. 

If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. 

If you have questions about this Safety Communication, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100. 

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