FDA: Don’t use antigen test made by Innova Medical Group

The Food and Drug Administration yesterday warned health care providers and the public not to use an antigen test for COVID-19 made by Innova Medical Group and distributed under several names. FDA has not authorized or approved the test, which was recalled April 23.

“The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health,” the agency said. Health care providers should destroy or return the test to Innova and consider retesting certain patients if they received the test in the past two weeks, FDA said.