June 14, 2021

FDA: Class I recall of Innova Medical Group’s COVID-19 test

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA), on June 10, announced the Class I recall of Innova Medical Group’s SARS-CoV-2 Antigen Rapid Qualitative Test.

The test, which claimed to determine if a person has an active COVID-19 infection, has not been authorized, cleared, or approved by the FDA for commercial distribution in the US.

Sponsored Message

Labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates seen during clinical trials of the tests. The test’s performance characteristics have not been adequately established, presenting a risk of false results.

Those affected include:

  • people tested with these tests
  • healthcare providers who use these tests or whose patients have used them
  • organizers of large testing programs, such as college campuses who use these tests for diagnostic use.

Distribution dates were November 2, 2020, to March 22, 2021.


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