FDA-Device2021-04-21Class II
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Roche Molecular Systems, Inc.
Hazard
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
Sold states
Nationwide WorldWide
Affected count
US: 5,430 units ; OUS 1528 units
Manufactured in
1080 US Highway 202 S, N/A, Branchburg, NJ, United States
Products
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1414-2021Don't want to check this manually?
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