FDA Issues Letter about Potential False Results with Roche cobas SARS-CoV-2 & Influenza Test

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  • FDA Issues Letter about Potential False Results with Roche cobas SARS-CoV-2 & Influenza Test

COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. Below are links to the most recent message on an FDA letter about potential false results with Roche cobas SARS-CoV-2 & Influenza Test.
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Lab Alert: FDA Issues Letter about Potential False Results with Roche cobas SARS-CoV-2 & Influenza Test

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.

 

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