03/02/2022: Lab Alert: FDA Says Do Not Use These Unauthorized COVID-19 Tests
Audience: Individuals Performing COVID-19 Testing
Level: Laboratory Alert
On March 1, 2022, the U.S. Food and Drug Administration (FDA) issued three safety communications:
Do Not Use Certain Celltrion DiaTrust COVID-19 Tests
Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests
Do Not Use Certain ACON Flowflex COVID-19 Tests
FDA is concerned about the risk of false results when using these unauthorized tests.
We encourage you to review these safety communications in detail and share this message widely with your networks.
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Online resources:
- Self-Testing at Home or Anywhere
- Interim Guidance for Antigen Testing for SARS-CoV-2
- Testing Strategies for SARS-CoV-2
- 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
Questions?
- 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.
Thank you,
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)