03/13/2021: Lab Alert: FDA Issues Letter about Potential False Results with Roche cobas SARS-CoV-2 & Influenza Test

CDC's Laboratory Outreach Communication System (LOCS)

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:

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/csels/dls/locs

Page last reviewed: March 13, 2021