Events

Rappel de cobas 8000 modular analyser series, control unit software version 03-03 (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-2013-RN-00293-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-04
  • 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-2013-RN-00293-1
  • 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
    When using the automatic dilution function on cobas e 602, a software bug occurs leading to an incorrect diluent being used during operation on certain elecsys assays. this happens when all three of the following conditions are present concurrently:- a total of > 2000 reagents kits or diluents had been registered on the cobas e 602 modules within one configuration; and- two or more different diluent types are available on board on the instrument (eg. diluent universal and diluent multiassay); and- a previous diluent (eg diluent universal) had been registered in the database with the identical key information has the current diluent of a different type (eg diluent multiassay).
  • Action
    Roche is providing work around instructions and a software correction is being developed.

Device

cobas 8000 modular analyser series, control unit software version 03-03 (An in vitro diagnostic m...
  • Modèle / numéro de série
    cobas 8000 modular analyser series, control unit software version 03-03 (An in vitro diagnostic medical device (IVD)) Affected Elecsys assays and their catalogue numbers:CA 15-3 II (03045838122)CMV IgM (04784618190)Anti-HAV IgM (11820591122)Anti-HBc IgM (11820567122)Rubella IgM (04618831190)Toxo IgM (04618858190)CMV IgG Avidity (05909708190)Cortisol (11875116122)Estradiol II (03000079190)N-MID Osteocalcin (12149133122)Toxo IgG (04618815190)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited