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The U.S. Food and Drug Administration is warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The concerns are:
- The performance of the test is not established and presents a health-risk.
- Labeling distributed with certain configurations of the test includes performance claims. These claims did not accurately reflect the performance estimates observed during the clinical studies of the tests.
- 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.
The Innova SARS-CoV-2 Antigen Rapid Qualitative Test is also distributed under the names:
- Innova COVID-19 Self-Test Kit (three tests)
- Innova SARS-CoV-2-Antigen Rapid Qualitative Test (seven tests)
- Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25 tests).