FDA: Class I recall of American Contract Systems’ COVID Test Kit Nonsterile, Clean Catch Urine Kit

Editor's Note

The Food and Drug Administration (FDA) on July 14 identified the recall of American Contract Systems’ COVID Test Kit Nonsterile and Clean Catch Urine Kit as Class I, the most serious.

The recall was initiated because the Kits were assembled in an uncontrolled facility by people without proper training. The company is unable to verify that the Kits will perform as expected.

The COVID Test Kit Nonsterile includes a nasopharyngeal swab and Universal Transport Media that are used to collect samples and detect SARS-CoV-2 infection. The Clean Catch Urine Kit is used to collect urine for further testing.

There have been no complaints or reports of injuries or deaths associated with these Kits.

Distribution dates were February 1, 2021, to March 31, 2022.