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MedWatch – The FDA Safety Information and Adverse Event Reporting Program
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Today, the U.S. Food and Drug Administration (FDA) posted an update to the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to share the latest information.
The update added new information about a potential impact on the performance of the Mesa Biotech Inc. Accula SARS-CoV-2 Test due to a genetic mutation at positions 28877-28878 (AG to TC) in patient samples.
Questions?
If you have questions about this update, email COVID19DX@fda.hhs.gov
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