March 29, 2022

FDA: Class I recall of certain Celltrion USA COVID-19 test kits labeled for research use only

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA), on March 23, identified the recall by Celltrion USA of certain point of care DiaTrust COVID-19 Ag Rapid Test kits (labeled for research use only) as Class I, the most serious.

The recall was initiated because the kits were distributed to customers who would be unlikely to use them for research use only and may not have the proper training to safely collect swab samples from patients. Emergency Use Authorization for this test is limited to authorized laboratories.

To date, there have been no reports of injuries, adverse health consequences, or deaths associated with the use of these test kits.

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