Events

Rappel de Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed to analyse biological samples for in vitro diagnostic purposes)

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-00923-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-15
  • 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-00923-1
  • 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
    Roche has received a complaint that one sample tube was opened inadvertently in a bulk loader module (blm) during the internal system transport. the opened sample tube fell down into the funnel and the sample material was spilled, contaminating the system and other samples on their outer surface. sample material could not be used to carry out the analysis.
  • Action
    To prevent the above malfunction, a hardware modification kit has been developed and will be released by the end of September 2015, with subsequent installation by a Roche field service engineer. Until the modification kit is installed Roche is requesting that if the issue occurs end users must carryout a complete instrument clean according to the Bulk Loader Module (BLM) operator manual. This action has been closed-out on 29/08/2016.

Device

Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed...
  • Modèle / numéro de série
    Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed to analyse biological samples for in vitro diagnostic purposes)Part Number: 07084285001All Lot NumbersAll Software versionsARTG Number: 212706
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited