Recall of Skippack Medical’s Unapproved COVID-19 Test Designated Class 1 by FDA

The FDA has classified the March 20 recall of Skippack Medical Lab’s SARSCoV2 Antigen Rapid Test Kit (Colloidal Gold) COVID-19, which was distributed in the U.S. without FDA authorization, as a Class 1 recall because of the potential for serious injury or death.

The 209,450 affected products were distributed by Tyrone, PA.-based SML Distribution to the states of Alabama, Florida, Georgia, Missouri, New York, Texas and Wyoming. The recalled products include five lots manufactured from Jan. 1, 2022, to Feb. 2, 2022.

The company said no false positive or negative test results had been reported as of the recall date but noted that false negative results could lead to lack of appropriate treatment for the individual and the further spread of COVID-19.