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Celltrion Recalls COVID-19 Point-of-Care Antigen Test Kits Due to Improper Distribution

NEW YORK – Celltrion USA has recalled its point-of-care COVID-19 antigen test because it was potentially distributed to unauthorized users, according to the US Food and Drug Administration. 

The Celltrion DiaTrust COVID-19 Ag Rapid Test, which received Emergency Use Authorization in April 2021, is authorized for use only by CLIA-certified laboratories, and use of the tests in unauthorized settings may lead to false results because the person performing them "may not have the qualifications or training to properly and safely administer them," the FDA said. It noted that there have been no reports of injuries, adverse health consequences, or death associated with use of the test kits.

The company, a subsidiary of South Korean firm Celltrion, began the Class I recall last month, and customers without CLIA certification were told to refrain from using any test kits currently in their inventory and return the product to the distributor. The recall covers up to 311,100 tests distributed from December 2021 to February 2022. 

In March, the firm recalled certain lots of the same test due to a high number of false-positive test results and a mislabeled shelf life. Also in March, the FDA warned against the use of certain Celltrion USA rapid antigen tests that hadn't been cleared by the agency for distribution or use in the US.