03/21/2022: Lab Alert: FDA Recalls Specific Lot Numbers of Celltrion DiaTrust™ COVID-19 Ag Rapid Test
Audience: Facilities Using the Celltrion DiaTrust™ COVID-19 Ag Rapid Test
Level: Laboratory Alert
The U.S. Food and Drug Administration (FDA) recently issued recalls for specific lot numbers of the Celltrion DiaTrust™ COVID-19 Ag Rapid Test:
FDA issued two Class 1 Device Recalls, the most serious type of recall, for the Celltrion DiaTrust™ COVID-19 Ag Rapid Test, Reference Number CT-P60 D-2 02. FDA initially authorized this test on April 16, 2021 for use at the point-of-care (POC) such as health clinics and congregate settings.
Class 1 Device Recall for Celltrion DiaTrust™ COVID-19 Ag Rapid Test – Lot Number COVGCCM0008
Tests with this lot number were placed on hold in September 2021 due to reports of false positive and false negative results.
Class 1 Device Recall for Celltrion DiaTrust™ COVID-19 Ag Rapid Test – Lot Numbers COVGCCF0001 and COVGCCF0002
Research Use Only (RUO) kits with these lot numbers were erroneously shipped to customers unlikely to use them for RUO purposes. The firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.
FDA has also issued a Class 2 Device Recall:
Class 2 Device Recall for Celltrion DiaTrust™ COVID-19 Ag Rapid Test – Lot Numbers COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, and COVGCCM1007
Test kits with these lot numbers have an incorrect expiration date or no expiration date.
We encourage you to review the recall notices in detail.
Share this message widely with your networks and invite them to opt in to LOCS to receive future updates.
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)