The Food and Drug Administration last week announced a Class 1 recall of the Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Test because it may have been distributed to unauthorized laboratories, which could increase the risk of false results. The test is authorized for emergency use only by laboratories certified under the Clinical Laboratory Improvement Amendments. Celltrion last month instructed customers to provide a CLIA certification number or return the test, among other actions.
- 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
What to Do
On April 5, 2022, Celltrion USA notified customers about this issue by email and instructed them to provide a CLIA Certificate Number and contact information to their distributor.
- Customers without CLIA certification were instructed to:
- Not use any test kits currently in inventory and quarantine them.
- Return the product to the distributor along with an acknowledgement and receipt form that was attached to the email. The distributor can provide shipping labels for product return.
Customers with questions or concerns about this recall may contact their distributors or Celltrion USA at celltrionusa.CS@celltrion.com.