Events

Rappel de 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).

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Roche Diagnostics Australia Pty Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-01032-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01032-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Modèle / numéro de série
    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