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

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Page last reviewed: May 2, 2022