05/03/2022: Lab Alert: Counterfeit COVID-19 Self-Tests

CDC's Laboratory Outreach Communication System (LOCS)

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.

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The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)