Lab Alert: Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test (06/11/2021)

Summary

CDC Laboratory Outreach Communication System lab alert dated 06/11/2021, addressed to individuals performing COVID-19 testing. It reports that the U.S. Food and Drug Administration (FDA) issued a safety communication telling test users, caregivers, health care providers and testing program organizers to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. FDA says it has significant concerns that the test's performance has not been adequately established and that the test is not authorized, cleared or approved for commercial distribution in the United States. It states the recall is classified as a Class I recall, the most serious type, and lists three other names for the test.

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06/11/2021: Lab Alert: Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test

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Audience : Individuals Performing COVID-19 Testing

Level : Laboratory Alert

The U.S. Food and Drug Administration (FDA) issued a safety communication 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 recall , 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:

We encourage you to review the safety communication in detail and share this message widely with your networks.

Opt in to receive emails from the CDC Laboratory Outreach Communication System (LOCS) .

Online Resources:

If you have any questions, please contact us at LOCS@cdc.gov .

Thank you,

Laboratory Outreach Communication System | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)

LOCS@cdc.gov

www.cdc.gov/locs

Last Reviewed: January 27, 2023

Source: CDC's Laboratory Outreach Communication System (LOCS)

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