06/11/2021: Lab Alert: Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test
Audience: Individuals Performing COVID-19 Testing
Level: Laboratory Alert
The U.S. Food and Drug Administration (FDA) issued a safety communicationexternal icon warning test users and caregivers, health care providers, and testing program organizers to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. FDA has significant concerns that the performance of the test has not been adequately established, and its use could present a health risk. Additionally, FDA has not authorized, cleared, or approved the test for commercial distribution or use in the United States, as required by law. The FDA has classified the recall of this test as a Class I recallexternal icon, the most serious type of recall.
The Innova SARS-CoV-2 Antigen Rapid Qualitative Test is also distributed under the following names:
- Innova COVID-19 Self-Test Kit (3T Configuration)
- Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration)
- Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration)
For listings of FDA-authorized tests, see:
- FDA-Authorized Molecular Diagnostic Tests for SARS-CoV-2external icon
- FDA-Authorized Antigen Diagnostic Tests for SARS-CoV-2external icon
We encourage you to review the safety communication in detail and share this message widely with your networks.
- Interim Guidance for Antigen Testing for SARS-CoV-2
- Testing Strategies for SARS-CoV-2
- Information for Laboratories about Coronavirus (COVID-19)
- Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories
- CDC Coronavirus (COVID-19) Website
- CDC Laboratory Outreach Communication System (LOCS)
- Clinical Laboratory COVID-19 Response Calls
If you have any questions, please contact us at LOCS@cdc.gov.