Home / Recalls / Roche Molecular Systems, Inc. / Z-0877-2021

Z-0877-2021 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
January 27, 2021
Initiation Date
November 23, 2020
Termination Date
May 22, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27

Product Description

uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001

Reason for Recall

When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.

Distribution Pattern

Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.

Code Information

version 1.1

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-1413-2021 Class II — cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavi (March 25, 2021)
  • Z-0846-2021 Class II — The cobas z 480 analyzer including dedicated software for IVD use is a plate-bas (November 19, 2020)