Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication

Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication

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  • Date Issued: June 10, 2021

The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Innova 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.

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 FDA has identified this recall as a Class I recall, the most serious type of recall.

LINK TO FDA =>https://www.fda.gov/medical-devices/safety-communications/stop-using-innova-sars-cov-2-antigen-rapid-qualitative-test-fda-safety-communication

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