UTAH (ABC4) – Consumers are being warned to avoid using counterfeit at-home over-the-counter (OTC) COVID-19 diagnostic tests distributed throughout the U.S.

The U.S. Food and Drug Administration (FDA) says people should be aware of using fake COVID-19 test kits and at-home testing becomes widely accessible.

“Counterfeit COVID-19 tests are tests that are not authorized, cleared, or approved by the FDA for distribution or use in the United States, but are made to look like authorized tests so the users will think they are the real, FDA-authorized test,” says the FDA. “The performance of these counterfeit tests has not been adequately established and the FDA is concerned about the risk of false results when people use these unauthorized tests.”

Health officials say depending on results from a counterfeit COVID-19 test may subject individuals to “unknowingly spreading COVID-19” and delay appropriate treatment for the illness.

Unauthorized tests can produce misleading results such as false negatives and false positive results.  

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

How do I know if my at-home OTC COVID-19 diagnostic test is FDA-authorized?

  • The FDA currently has an updated list of authorized at-home OTC COVID-19 diagnostic tests. 
  • Users suspecting a test’s authenticity can use this site as a reference to compare their tests. Concerned customers can also contact the test’s manufacturer to determine whether the test is FDA-authorized or counterfeit.

Some signs to look out for when identifying counterfeit COVID-19 tests include:

  • Poor print quality of images or text on box label or test instructions.
  • Missing information on the outside box label such as the lot number, expiration date, or barcode or QR codes.
  • Grammatical or spelling errors found in product labeling.
  • Kit components not matching the content description such as missing instructions, missing or unfilled components, different number of components than listed, etc.
  • Trade name for product printed on component or box labels differ from the authorized labeling found on the FDA website.
  • The box label or printed instructions look different from the authorized labeling found on the FDA website.

If you suspect your test may be a counterfeit test, you should contact the store where the test was purchased and notify the authorized test manufacturer. Customers should also follow the manufacturer’s instructions for returning or disposing of the test.

“The distribution of counterfeit COVID-19 products is a threat to the public health,” says the FDA. “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 manufacturers to address this safety issue. The FDA will continue to keep the public informed of significant new information.”

How do I report a problem with an at-home OTC COVID-19 diagnostic test?

  • If you think you had a problem with a COVID-19 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.