Events

Rappel de IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottles

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-2015-RN-00201-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-12
  • 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-00201-1
  • 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 is conducting a correction for the immulite 2000 / immulite 2000 xpi immunoassay systems water and liquid waste bottles received from may 2013. siemens has identified that the water and liquid waste bottle assemblies were manufactured with a quality issue. the opening of both bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.This could result in the aspiration straw dislodging from the bottle causing the instrument to aspirate air into the fluidic line potentially resulting in discordant results.
  • Action
    Siemens is providing work around instructions to assist end users to mitigate risk and identify faulty bottle openings. If a faulty bottle is identified end users are requested to contact Siemens for a replacement.

Device

IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottles
  • Modèle / numéro de série
    IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottlesSiemens Material Numbers: 10291586 and 10291587ARTG number: 174399
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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