FDA Provides Update on American Contract Systems’ Recall of Its COVID-19 and Urine Test Kits

The FDA has issued an update on American Contract Systems’ May 2 recall of two test kits, one for COVID-19 and another for urine, deeming it a Class 1 recall because of the risk of serious injury or death.

The reason for the recall is that affected products were assembled off-site by individuals who may not have been properly trained, the agency said.

The FDA instructed customers to destroy or discard the 274,400 affected COVID Test Kit Nonsterile and the Clean Catch Urine Kit products. No injuries or deaths have been reported for either product, the agency said.