FDA Announces Recall of Tens of Thousands of Unapproved COVID Test Kits

The U.S. Food and Drug Administration in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images

A recall was issued for more than 56,000 COVID-19 rapid tests last week because they were not distributed with the proper clearance from the Food and Drug Administration (FDA), according to an announcement posted on its website.

Some 56,000 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits are being recalled by its maker, Universal Meditech Inc., because the “products were distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA,” according to an FDA notice, dated Feb. 10.