American Contract Test Kits Recall is Class 1

FDA says the American Contract Systems 5/1 recall of 166,400 Covid Test Kits Nonsterile and Clean Catch Urine Kits is Class 1. An FDA notice says the kits were distributed between 2/1/21 and 3/31/22 and were recalled because they were assembled in an uncontrolled facility by people without proper training. As a result, FDA says, the company is unable to verify that the kits will perform as expected. The agency says the kits have the potential to give false negative or false positive results or lead to misinterpretation of test results.

The notice says the Covid Test Kit Nonsterile includes a nasopharyngeal swab and universal transport media and is intended to collect samples that are used to detect infection with SARS-CoV-2. The Clean Catch Urine Kit is used to collect urine for further testing, including to test for potential urinary tract infection, the notice says.