to resolve this safety issue.ĪCON Laboratories, Inc. The FDA is working with ACON Laboratories, Inc. The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are housed together. A false-positive result may lead to a delay in both the correct diagnosis and appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease that is not COVID-19.

A false-positive antigen test result means that the test says the person has COVID-19 but they are actually do not have COVID-19.

When false negative test results are received, actions to limit exposure to an infected person might not be taken, such as isolating people, limiting contact with family and friends, or limiting access to places of employment. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are housed together in health care, long-term care, and other facilities based on these false test results. A false-negative result may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death.

A false-negative antigen test result means that the test says the person does not have COVID-19 but they actually do have COVID-19.

The ACON Laboratories Flowflex COVID-19 Antigen Home Test, authorized by the FDA on October 4, 2021, is not the subject of this Safety Communication and can continue to be used.

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” and the name ACON Biotech (Hangzhou) Co., Ltd.

The unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) uses a nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19.

Report any problems you experience with the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) to the FDA, including suspected false results.

If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.

Health care providers and testing program organizers: If an antigen test was performed less than two weeks ago using the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), consider retesting your patients using an FDA authorized SARS-CoV-2 diagnostic test if you suspect an inaccurate result.

Test users and caregivers: Talk to your health care provider if you think you were tested with the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) and you have concerns about your test results.

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

The FDA is concerned about the risk of false results when using this unauthorized test. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States.

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). Food and Drug Administration (FDA) is warning people not to use certain ACON COVID-19 tests, a product of ACON Biotech (Hangzhou) Co., Ltd. Do Not Use Certain ACON Biotech Flowflex COVID-19 Tests: FDA Safety Communication 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.

Flex flow covid test