FDA MedWatch - Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test

FDA Safety Communication

MedWatch - The FDA Safety Information and Adverse Event Reporting Program Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test - FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication 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. The test 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. In addition, 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), InnovaSARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration). This safety communication provides: Information about the Innova SARS-CoV-2 Antigen Rapid Qualitative Test and Recall Notice. Recommendations for test users, health care providers, and testing program organizers. Details on the FDA's actions with respect to the test. Instructions for reporting problems with the Innova SARS-CoV-2 Antigen Rapid Qualitative Test to the FDA. Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education.

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