Home / Recalls / Roche Molecular Systems, Inc. / Z-1413-2021

Z-1413-2021 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
April 21, 2021
Initiation Date
March 25, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
US: 143,823 kits Ex-US: 57,219 kits

Product Description

cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190

Reason for Recall

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

Distribution Pattern

Nationwide WorldWide

Code Information

All lot numbers

Other recalls by Roche Molecular Systems, Inc.

  • Z-1106-2023 Class II — cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for (December 21, 2022)
  • 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-1105-2023 Class II — cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the co (December 21, 2022)
  • Z-0097-2023 Class II — cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase C (September 8, 2022)
  • Z-0828-2022 Class II — cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Nu (November 16, 2021)
  • 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-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)