COVID-19 antigen test recalled after officials say it was counterfeit, not FDA approved

A coronavirus antigen test has been recalled after officials discovered that it was a counterfeit and not approved by the Food and Drug Administration (FDA) for use in the United States. 

ACON Laboratories Inc., which legally manufacturers the FDA-approved Flowflex COVID-19 Antigen Home Test, discovered "the U.S. distribution of unauthorized, adulterated and misbranded counterfeit product having the trade name Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)," according to the recall notice posted by the FDA. 

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ACON says it's not importing the "Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)" into the United States and that it's "only authorized for sale in Europe and other markets, under the CE mark."

Since the test has not been approved by the FDA, it can't legally be imported, distributed, or used in the U.S. market, the recall continued.  

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

There have been no reports of "adverse events" related to the recalled test.

However, "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," ACON said.

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Getting a false-positive antigen test can delay the "correct diagnosis and the initiation of an appropriate treatment for the actual cause of a person’s illness," the company continued. 

The company noted that this recall does not impact the FDA authorized Flowflex COVID-19 Antigen Home Test in the United States.