FDA warned the public to stop using the Innova SARS-CoV-2 antigen rapid qualitative test for diagnostic use. The agency said it has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, 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. Finally, the test has not been authorized, cleared, or approved by FDA for commercial distribution or use in the United States, as required by law.
The test in question is also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration).
Innova Medical Group recalled the test on April 23, and FDA considers it to be a Class I recall, the most serious type of recall.
FDA recommendations for Innova test users, healthcare providers, and testing program organizers
- Stop using the test.
- Destroy the tests by placing them in the trash, or return the tests to the company using the FedEx return label that was included with the recall letter that was sent to customers.
- Test users and caregivers: Talk to your healthcare provider if you think you were tested with the Innova SARS-CoV-2 antigen rapid qualitative test and you have concerns about your test results.
- Healthcare providers: If the test was given less than two weeks ago, consider retesting your patients using a different SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
- Testing program organizers: Notify participants in your testing program to discontinue diagnostic use of the Innova test and to use an FDA-authorized test to continue testing. For listings of FDA-authorized tests, see:
- Report any problems you experience with the test to FDA, including suspected false results.