FDA issues Class 1 recall of COVID-19 rapid test

Editor's Note

The Food and Drug Administration (FDA) announced on March 28 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,” the American Hospital Association (AHA) May 2 reports.

A Class 1 recall is “the most serious type of recall,” the FDA emphasizes. The recalled test is authorized for emergency use only by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA), but it may have been distributed to customers that do not possess this certification. CLIA-certified laboratories must meet specific criteria that qualify them perform diagnostic tests. Use of these tests in unauthorized settings without the CLIA certification, the FDA warns, may increase the risk of false results and lead to further exposure.

According to the FDA, there have been no reports of injuries or other adverse health consequences from the possible wrongful distribution. Celltrion USA started notifying customers of the recall on April 5, and it is instructing customers to either provide a CLIA certification number or return the test, AHA notes.