 MedWatch - The FDA Safety Information and Adverse Event Reporting Program
The U.S. Food and Drug Administration (FDA) is aware of counterfeit versions of the following at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States:
- Counterfeit Flowflex COVID-19 Test Kits
- Counterfeit iHealth COVID-19 Antigen Rapid Test Kits
These counterfeit tests should not be used or distributed.
The FDA’s new web page provides information on how to check whether you have a counterfeit test and what to do if you use a counterfeit test. The FDA will update this page to list counterfeit at-home OTC COVID-19 diagnostic tests when significant new information becomes available.
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 performance of these tests has not been adequately established and the FDA is concerned about the risk of false results when people use these unauthorized tests. If you use a counterfeit test, you may risk unknowingly spreading COVID-19 and may delay or stop appropriate medical treatment for COVID-19.
The FDA is not aware of any counterfeit tests distributed by the U.S. Government test distribution programs.
Questions?
If you have questions about counterfeit at-home OTC COVID-19 diagnostic tests, contact the Division of Industry and Consumer Education
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