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Roche Molecular Systems, Inc. recalls cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Recalled April 6, 2022 · FDA recall Z-0828-2022 · Roche Molecular Systems
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. · FDA Class II
Units
14 units
Sold at
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.
Description
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.
Product
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Manufacturer(s)
Roche Molecular Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →