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# Stop Using Innova Covid Tests: FDA
- URL: https://www.fdaweb.com/stop-using-innova-covid-tests-fda/
- Published: 2021-06-10T12:00:00.000Z
- Updated: 2026-09-14T17:02:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149513

FDA says the public should stop using the Innova SARS-CoV-2 antigen rapid qualitative test for diagnostic use due to the agency’s “significant concerns that the performance of the test has not been adequately established, presenting a risk to health.” An agency [notice](https://www.fda.gov/medical-devices/safety-communications/stop-using-innova-sars-cov-2-antigen-rapid-qualitative-test-fda-safety-communication?ref=fdaweb.com) says that labeling distributed with certain configurations of the test reflects performance estimates observed during clinical studies and that the test has not been authorized, cleared, or approved by FDA.

The notice says Innova Medical Group [recalled](https://www.fda.gov/medical-devices/medical-device-recalls/innova-medical-group-recalls-unauthorized-sars-cov-2-antigen-rapid-qualitative-test-risk-false-test?ref=fdaweb.com) its SARS-CoV-2 antigen rapid qualitative test on 4/23\. FDA has said it is a Class 1 recall.

The company says the performance characteristics of the test have not been adequately established, presenting a risk of false positive and false negative results.