FDA: Class I recall of North American Diagnostics’ COVID-19 test

Editor's Note

The Food and Drug Administration (FDA) on August 1 identified the recall by North American Diagnostics of its Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits as Class I, the most serious.

These tests are being recalled because they were distributed in the US without authorization, clearance, or approval from the FDA. The company did not provide the FDA with adequate validation data to show that the test’s performance is accurate.

There have been no complaints or reports of injuries or deaths associated with the tests. Distribution dates were March 1, 2021, to February 15, 2022.