05/02/2022: Lab Alert: Celltrion USA Recalls Certain Point-of-Care DiaTrust™ COVID-19 Ag Rapid Test Kits
Audience: Facilities Using Celltrion DiaTrust™ COVID-19 Ag Rapid Test Kits
Level: Laboratory Alert
Celltrion USA recently recalled certain point-of-care DiaTrust™ COVID-19 Ag Rapid Test Kits because these test kits may have been distributed to unauthorized users.
The U.S. Food and Drug Administration (FDA) identifies this as a Class 1 recall, the most serious type of recall.
Please review the recall notice in detail and share this message widely with your networks.
Recalled Product Information
- Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test
- Product Codes: 83QKP
- Lot Numbers: See recall database entry
- Distribution Dates: December 2021 to February 2022
- Devices Recalled in the U.S.: Up to 311,100 units
- Date Initiated by Firm: April 4, 2022
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Online resources:
- Guidance for Antigen Testing for SARS-CoV-2 for Healthcare Providers Testing Individuals in the Community
- Guidance for SARS-CoV-2 Rapid Testing Performed in Point-of-Care Settings
- 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)