Home / Recalls / Roche Molecular Systems, Inc. / Z-0828-2022

Z-0828-2022 Class II Ongoing

Recalled by Roche Molecular Systems, Inc. — Branchburg, NJ

Recall Details

Product Type
Devices
Report Date
April 6, 2022
Initiation Date
November 16, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 units

Product Description

cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

Reason for Recall

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.

Distribution Pattern

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.

Code Information

UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086

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  • Z-1104-2023 Class II — cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/880 (December 21, 2022)
  • Z-0097-2023 Class II — cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase C (September 8, 2022)
  • Z-0083-2022 Class II — cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Numb (September 3, 2021)
  • Z-2498-2021 Class II — cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog (August 4, 2021)
  • Z-1414-2021 Class II — cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog (March 25, 2021)
  • Z-1413-2021 Class II — cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavi (March 25, 2021)
  • Z-0877-2021 Class II — uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 (November 23, 2020)
  • Z-0846-2021 Class II — The cobas z 480 analyzer including dedicated software for IVD use is a plate-bas (November 19, 2020)