"The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. Finally, the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law...
Potential Risk of False Results
The Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test claimed to determine if a person had an active COVID-19 infection using a nasal swab sample and test strip. The Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test, however, does not have authorization, clearance, or approval from the FDA. In addition, the FDA has significant concerns that the performance of the Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test device has not been adequately established, presenting a risk of false results...
FDA Actions
The FDA has classified the recall of this test as a Class I recall, the most serious type of recall. The FDA also has issued a warning letter to Innova Medical Group, Inc."
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