The FDA is urging the public to stop using a rapid COVID-19 antigen test made by Innova Medical Group after discovering the company was selling the test without its approval and that it carries the risk of false positive and false negative results.
The agency said it has "significant concerns" that the performance of Innova's SARS-CoV-2 Antigen Rapid Qualitative Test "has not been adequately established, presenting a risk to health."
The FDA told providers to put the tests in the trash or return them to Innova.
Innova, a diagnostic test maker based in Pasadena, Calif., has recalled at least 77,339 of the tests, according to the FDA. The agency classified the recall as class 1, the most serious type of recall, meaning use of the devices can cause serious injury or death. The FDA said it hasn't received reports of injuries or death associated with use of the test.
Innova claimed the test could determine whether a person has an active COVID-19 infection, but it was not authorized, cleared or approved by the FDA for commercial use in the U.S. The test came with a label that included claims that "did not accurately reflect performance estimates observed during clinical studies," the FDA said.
Because the test's performance wasn't adequately established in clinical trials, the test presents the risk of false negative and false positive results, the FDA said.
The FDA is recommending people talk to their healthcare providers if they believe they were tested with Innova's COVID-19 test and have concerns about their results. It's also recommending that healthcare providers retest patients who were tested with Innova's test within the last two weeks.
Read the FDA's full news release here.