Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on the cobas Liat System

“Please be advised that all medical practices in New York State are receiving this notification from the New York State Physician Office Laboratory Evaluation Program (POLEP), whether they perform this testing or not. Please contact POLEP at clia@health.ny.gov if you have questions related to why you’ve received this notification.


The U.S. Food and Drug Administration (FDA) issued a Letter to Clinical Laboratory Staff, Point-of-Care Staff, and Health Care Providers to alert them that false positive results can occur with the Roche Molecular Systems, Inc. cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test for use on the cobas Liat System.


For additional information, see the FDA website at https://www.fda.gov/medical-devices/letters-health-care-providers/potential-false-results-roche-molecular-systems-inc-cobas-sars-cov-2-influenza-test-use-cobas-liat.”

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