Celltrion USA is recalling up to 311,000 affected POC DiaTrust COVID Rapid Tests because the tests may have been distributed to unauthorized users. This test is authorized for use only by laboratories with CLIA certification and a corresponding CLIA Certificate Number (CCN).

The Point of Care (POC) Celltrion DiaTrust COVID Rapid Test is intended to detect the presence of SARS-CoV-2, the virus that causes COVID-19, based on a nasopharyngeal (deep inside the nose to the back of the throat) swab sample from patients. The sample is collected by healthcare providers.

CLIA-certified laboratories must meet specific criteria that qualify them to perform diagnostic tests. Emergency use of these tests is limited to authorized laboratories and use of these tests in unauthorized settings (for example, customers without CLIA -certification) may present an increased risk of false results as the persons performing these tests may not have the qualifications or training to properly and safely administer them.

Although there have been no reports of injuries, adverse health consequences, or death associated with the use of these affected products, false positive or false negative results from improper use of these tests could lead to further exposure of uninfected individuals to SARS-CoV-2 virus. There are also serious injury risks if someone who is not trained to collect a nasopharyngeal swab sample attempts to do so.

Celltrion DiaTrust COVID Rapid Test Recall Info:

  • Product Name: Celltrion DiaTrust COVID 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

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.