01/13/2022: Lab Alert: Stop Using LuSys Laboratories COVID-19 Tests
Audience: Individuals Performing COVID-19 Testing
Level: Laboratory Alert
On January 11, 2022, the U.S. Food and Drug Administration (FDA) issued a safety communication warning test users, caregivers, and healthcare personnel to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and FDA believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by FDA for distribution or use in the United States.
The LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx. The FDA believes that these tests were distributed for use in laboratories or for at-home testing.
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 are a clinical or public health laboratory professional, contact LOCS.
- For media inquiries, contact the CDC Newsroom.
- For all other questions, contact CDC-INFO.