05/03/2022: Lab Alert: Counterfeit COVID-19 Self-Tests
Audience: Individuals Performing COVID-19 Testing
Level: Laboratory Alert
The U.S. Food and Drug Administration (FDA) has recently published a website about counterfeit COVID-19 self-tests. Counterfeit versions of the following COVID-19 self-tests are being used and distributed in the United States:
- Counterfeit Flowflex™ SARS-CoV-2 Antigen Rapid Tests (Self-Testing)
- Counterfeit iHealth COVID-19 Antigen Rapid Test Kits
Please review the FDA website and do not use or distribute these counterfeit tests.
FDA has not authorized, cleared, or approved these tests for use or distribution in the United States, but they are made to look like authorized tests so that users will think they are real, FDA-authorized tests. FDA is concerned about the risk of false results when people use these counterfeit tests.
FDA is not aware that U.S. Government test distribution programs have distributed any counterfeit tests.
- Self-Testing At Home or Anywhere
- Information for Laboratories about Coronavirus (COVID-19)
- Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories
- CDC Coronavirus (COVID-19) Website
- CDC Laboratory Outreach Communication System (LOCS)
- Clinical Laboratory COVID-19 Response Calls
- If you are a clinical or public health laboratory professional, contact LOCS.
- For media inquiries, contact the CDC Newsroom.
- For all other questions, contact CDC-INFO.