FDA-Device2022-04-06Class II
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Roche Molecular Systems, Inc.
Hazard
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
Sold states
Worldwide distribution - US Nationwide distribution in the states of CO, IL, IN, KY, MI, NC, and TX. The countries of Cyprus, Spain, and Hong Kong.
Affected count
14 units
Manufactured in
1080 US Highway 202 S, N/A, Branchburg, NJ, United States
Products
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0828-2022Don't want to check this manually?
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