FDA: Stop using Innova SARS-CoV-2 Antigen Rapid Qualitative Test

June 14, 2021

The U.S. Food and Drug Administration (FDA) has issued a safety communication warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test.

The FDA also has issued a Class 1 recall of the product, which has not been approved by the agency for commercial distribution or use in the United States.

“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.”

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).

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