The FDA says it is “aware” of counterfeit home COVID tests being distributed or used in the US and warns the tests should not be used or distributed.
Counterfeit Home COVID 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 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:
- Counterfeit Flowflex COVID-19 Test Kits
- Counterfeit iHealth COVID-19 Antigen Rapid Test Kits
The FDA says 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. Meanwhile, a false-positive antigen test result means that the test says the person has COVID-19 but they actually do not have COVID-19. A false-positive result may lead to a delay in both the correct diagnosis and appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease that is not COVID-19.
The FDA has a list of authorized at-home OTC COVID-19 diagnostic tests. For more information about each test, including the Letter of Authorization and authorized labeling, see In Vitro Diagnostics EUAs: Tables of IVD EUAs.
Signs of a Potential Counterfeit Home 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.