The Food and Drug Administration (FDA), on June 10, announced the Class I recall of Innova Medical Group’s SARS-CoV-2 Antigen Rapid Qualitative Test.
The test, which claimed to determine if a person has an active COVID-19 infection, has not been authorized, cleared, or approved by the FDA for commercial distribution in the US.
Labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates seen during clinical trials of the tests. The test’s performance characteristics have not been adequately established, presenting a risk of false results.
Those affected include:
Distribution dates were November 2, 2020, to March 22, 2021.Read More >>