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Watch Out for Fake COVID-19 Tests, FDA Warns

by | May 4, 2022 | Articles, News, Open Content

Agency warns the public to be on the lookout as counterfeit at-home OTC COVID-19 diagnostic tests appear on the US market.

Counterfeit at-home over-the-counter (OTC) COVID-19 tests are becoming enough of a problem that the FDA sent out a warning regarding their use and distribution in the US on April 29.

Though these tests look like the real deal, the FDA stresses that the tests have not been authorized, cleared, or approved by the agency for use or distribution in the US.

“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,” the FDA said in its recent communication, adding that people who use these tests put others at risk if they get a false negative as well as themselves if they delay treatment due to a false negative. False positives can also cause problems as people may not receive the right treatment for the illness they do have, or may be housed with those who actually have COVID-19, putting them at risk of infection, the FDA states.

The FDA says it will update its page on counterfeit COVID-19 tests to share information on how to tell if tests are fake (spelling mistakes and missing information such as barcodes on packages/labels are some signs to look for) and to list counterfeit at-home OTC COVID-19 diagnostic tests so the public and other key stakeholders can avoid these tests. Currently, the page lists the following kits to watch out for:

  • Counterfeit Flowflex COVID-19 Test Kits
  • Counterfeit iHealth COVID-19 Antigen Rapid Test Kits

In addition to fake test kits to look out for and how to identify counterfeit tests, the FDA page also provides information on how to tell if OTC COVID-19 tests are FDA authorized, what people should do if they have a counterfeit test kit, what the FDA is doing about these fake kits, and how to report problems with at-home OTC COVID-19 diagnostic tests.

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