Company recalls unauthorized COVID-19 tests

 The Food and Drug Administration warns consumers of counterfeit COVID-19 antigen home tests being distributed in the United States.

ACON Laboratories, Inc., the  manufacturer of the "Flowflex™ COVID-19 Antigen Home Test", says it has identified the U.S. distribution of unauthorized, adulterated, and misbranded counterfeit products having the trade name "Flowflex SARS-CoV-2 Antigen Rapid Test."

ACON said the "Flowflex SARS-CoV-2 Antigen Rapid Test" is not being imported into the U.S. and is only authorized for sale in Europe and other markets under the CE mark.

The "Flowflex SARS-CoV-2 Antigen Rapid Test" has not been approved, cleared, or authorized by the FDA.

 The "Flowflex COVID-19 Antigen Home Test" cannot be legally imported, distributed, or used in the European market as it is not CE marked.

 The two products have been authorized by the U.S. FDA and registered under CE Mark authorities separately under different product registration requirements.

The recall has no impact on the distribution and use of the CE marked "Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)" in Europe and other markets outside of the U.S., and no impact on the distribution and use of the FDA authorized "Flowflex COVID-19 Antigen Home Test" in the United States.

COVID-19 Antigen tests in the U.S. market that lack FDA approval, clearance, or authorization can pose a significant risk since they may lead to inaccurate test results, including false-negative or false-positive test results.

False-negative antigen test results may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm, including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are grouped into cohorts (that is, they are housed together) in health care, long-term care, and other facilities based on these false test results.

Actions to limit exposure based on false-negative results might not be taken, such as isolating people, limiting contact with family and friends, and limiting the ability to work.

False-positive antigen test results may lead to a delay in both the correct diagnosis and the initiation of appropriate treatment for the actual cause of a person's illness, which could be another life-threatening disease that is not COVID-19.

False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together).

To date, ACON Laboratories has not received any reports of adverse events related to the products addressed in this public press release and is issuing this recall out of an abundance of caution.

If you have received the "Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)" with the blue box in the U.S. market, you should stop using this product and dispose of it. The product has not been approved, cleared, or authorized for use in the U.S.

To help differentiate the recalled product from the FDA authorized product, please find the table below, highlighting differences in the product kit box labeling. Note that the CE-marked product has "ACON Biotech (Hangzhou) Co., Ltd." as the manufacturer in place of "ACON Laboratories, Inc."

Not FDA Authorized (Recalled Product)  FDA Authorized Product

ACON says it is working with the FDA and other law enforcement agencies to ensure that only the FDA authorized "Flowflex COVID-19 Antigen Home Test" is distributed in the U.S. Any distribution of the "Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)" should be reported immediately to ACON Laboratories and the FDA at the numbers provided below.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178