June 28, 2021

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).

Read the full FDA notice.