FDA Issues Warning About Counterfeit Covid Tests

FDA Issues Warning About Counterfeit Covid Tests

On top of the increasing number of covid-related infections and deaths, last week the Food and Drug Administration put out a warning that the public needs to be aware of counterfeit at-home over the counter (OTC) COVID-19 diagnostic tests circulating in the United States.

According to a press release from the FDA, "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."

The FDA is currently aware of two counterfeit at-home diagnostic tests: counterfeit Flowflex COVID-19 Antigen Home Tests and iHealth COVID-19 Antigen Rapid Test Kits.

Here are some of the signs to look for in order to detect a counterfeit covid test:

  • Poor print quality of images or text on the outside box label for the product or in the instructions for use included in the box.
  • Missing information on the outside box label for the product, such as the lot number, expiration date, or barcode or QR codes.
  • Grammatical or spelling errors found in product labeling.
  • Components of the kits do not match the content description (for example, missing Instructions for Use, missing or unfilled components, different number of components than listed).
  • Tradename for product printed on component or box labels differ from the authorized labeling found on the FDA website: At-Home OTC COVID-19 Diagnostic Tests | FDA.
  • The box label or printed instructions for use look different from the authorized labeling found on the FDA website: At-Home OTC COVID-19 Diagnostic Tests | FDA.

You can more information about the FDA warning here: Counterfeit Covid Tests

Close