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MedWatch – The FDA Safety Information and Adverse Event Reporting Program
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FDA issues Letter to Clinical Laboratory Staff, Point-of-Care Staff, and Health Care Providers
Today, 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.
This Letter to Health Care Providers includes important information about the cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test for use 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 using the cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test.
- Actions the FDA has taken to address the issues.
Instructions for reporting adverse events with a device to the FDA.
Questions?
If you have questions, email COVID19Dx@fda.hhs.gov.
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