Events

Recall of BenchMark ULTRA with software versions VSS 11.9 or higher, and DISCOVERY ULTRA clinical chemistry analysers (used for detecting and preparing tissue morphology and components). An in vitro diagnostic medical device (IVD).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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
    RC-2015-RN-01032-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01032-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • 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
    Roche is advising users to use same-slide controls as per the package insert and review run reports at the end of each run to ensure the intended staining protocol was used on each slide. Additionally, ensure each host has an adequate keycode range allocated. Roche will be performing a software upgrade as a permanent correction. This action has been closed-out on 26/08/2016.

Device

BenchMark ULTRA with software versions VSS 11.9 or higher, and DISCOVERY ULTRA clinical chemistry...
  • Model / Serial
    BenchMark ULTRA with software versions VSS 11.9 or higher, and DISCOVERY ULTRA clinical chemistry analysers (used for detecting and preparing tissue morphology and components). An in vitro diagnostic medical device (IVD).BenchMark ULTRA instrument Material Number: 05342716001Software versions VSS 11.9 or higherDISCOVERY ULTRA instrumentMaterial Number: 05987750001ARTG number: 173917
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited