Events

Rappel de Cobas 8000 'v2' instrument drivers for Cobas IT 3000 (Used with Cobas IT 3000 versions 2.03.08 to 2.04.00); 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-2012-RN-00783-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-08-06
  • 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-2012-RN-00783-3
  • 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
    There is a potential for incorrect handling of extra-long result messages that are sent form the cobas® 8000 data manager and received into it 3000 using a “v2” instrument driver. this is applicable for messages that are greater than 33 results in length per episode and if the configuration of the predefined buffer size is not optimal. the “v2” instrument drivers for cobas® 8000 use a buffer to ensure that extra-long result messages are processed correctly. if this buffer is not configured for the specific driver that is installed, then there can be a mismatch in the amount of data that is truncated. the effect of this being that results and flags after result #33 in the string may be delayed and in some cases may not be reported to cobas® it 3000.
  • Action
    Roche are providing work around instructions until a software upgrade can be implemented to permanently fix the issue.

Device

Cobas 8000 'v2' instrument drivers for Cobas IT 3000 (Used with Cobas IT 3000 versions 2.03.08 to...
  • Modèle / numéro de série
    Cobas 8000 'v2' instrument drivers for Cobas IT 3000 (Used with Cobas IT 3000 versions 2.03.08 to 2.04.00); An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited