FDA Safety Communication on Innova SARS-CoV-2 Antigen Rapid Qualitative Test

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.

The Innova SARS-CoV-2 Antigen Rapid Qualitative Test is also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration).

On April 23, 2021, Innova Medical Group recalled their Innova SARS-CoV-2 Antigen Rapid Qualitative Test. 

The Innova SARS-CoV-2 Antigen Rapid Qualitative Test claimed to determine if a person had an active COVID-19 infection. The test uses a nasal swab sample and test strip to detect specific proteins, called antigens, from the SARS-CoV-2 virus. If the nasal sample had SARS-CoV-2 antigens, a colored test line should have appeared on the test strip indicating a person may have COVID-19. If the nasal sample did not have SARS-CoV-2 antigens, a colored line should not have appeared on the test strip. The test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it has been recalled by Innova Medical Group, Inc. 

Click here to read the FDA communication