Events

Rappel de ADVIA Centaur and Centaur XP Instrument Systems (immuno-assay analysers). 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 Siemens Ltd Diagnostics Division.

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-01139-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-14
  • 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-01139-1
  • 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
    Siemens healthcare diagnostics has confirmed occurrences of the system either:- failing to detect that the wash 1 bottle and reservoir is empty, or- incorrectly indicating that the wash 1 bottle and reservoir is empty when it is actually full.If the system fails to detect an empty wash 1 bottle and reservoir, it can continue to process samples and product erroneous but believable results which are falsely high or low (depending if the assay architecture is direct or indirect). this issue potentially affects only those assays that use wash 1.
  • Action
    Siemens is providing work around instructions for users to follow.

Device

ADVIA Centaur and Centaur XP Instrument Systems (immuno-assay analysers). An in vitro diagnostic ...
  • Modèle / numéro de série
    ADVIA Centaur and Centaur XP Instrument Systems (immuno-assay analysers). An in vitro diagnostic medical device (IVD)Catalogue numbers: 078-A001-xx and 078-A011-03 (respectively)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA