FDA Provides Update on North American Diagnostics’ Recall of SARS-CoV-2 Test Kits

The FDA has issued an update on North American Diagnostics’ June 15 recall of its SARS-CoV-2 test kits, deeming it a Class 1 recall because of the risk of serious injury or death.

The 122,175 affected products were distributed from March 1, 2021 to February 15. The test kits were distributed to U.S. customers without authorization, clearance or approval from the FDA.

The company also failed to provide adequate validation data to show that the test is accurate, which means there is a risk of potential false negative, false positive or misinterpretation of results, the agency said.

So far, no complaints or reports of injuries or deaths have been linked to the test kits, the FDA said.