03/13/2021: Lab Alert: FDA Issues Letter about Potential False Results with Roche cobas SARS-CoV-2 & Influenza Test
Audience: Individuals Performing COVID-19 Testing
Level: Laboratory Alert
On March 12, 2021, the U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff, Point-of-Care Staff, and Health Care Providers about false positive results that can occur with the Roche Molecular Systems, Inc. cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test used on the cobas Liat System.
This letter includes important information about the cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test used on the cobas Liat System, including:
- Details on potential causes of false results with the cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test.
- Recommendations for cobas Liat System operators who use the cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test.
- Actions the FDA has taken to address the issue.
- Instructions for reporting adverse events with a device to the FDA.
For questions about this letter, email COVID19DX@fda.hhs.gov.
Please share this message with your networks and invite them to opt in to LOCS to receive future updates.
Online resources:
- 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.
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)