05/02/2022: Lab Alert: Celltrion USA Recalls Certain Point-of-Care DiaTrust™ COVID-19 Ag Rapid Test Kits

CDC's Laboratory Outreach Communication System (LOCS)

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

Opt in to receive emails from the CDC Laboratory Outreach Communication System (LOCS).

Online resources:


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)