Events

Recall of Roche Benchmark Ultra clinical chemistry analysers

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    19310
  • Event Initiated Date
    2015-10-30
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    Internal investigations by roche diagnostics have uncovered the potential for incorrect slide staining (ihc/ish) to occur on the benchmark ultra instrument or discovery ultra instrument running ventana system software (vss) 11.9 or higher, due to the possibility of a duplicate keycode error., the embedded software for the barcode reader has an identified issue, which on presentation of this error may result in two slides erroneously receiving the same stain protocol regardless of what should have been indicated in the software for that keycode. the barcode reader fails to purge previously read barcode information and applies the same protocol details to a subsequent slide.
  • Action
    Software to be upgraded

Device

Roche Benchmark Ultra clinical chemistry analysers
  • Model / Serial
    Model: 5342716001, Affected: Software Versions VSS 11.9 or higher
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479