Events

Rappel de Siemens Immulite 2000/ Immulite 2000 xPi IGF-1

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Siemens Healthcare Diagnostics Products 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
    13811
  • Date de mise en oeuvre de l'événement
    2012-11-19
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Cause
    The manufacturer has confirmed a positive shift in patient medians of approximately 20% with the igf-1 assay. siemens has determined that an initial positive shift of approximately 15% occcurred with immuliate 2000/ immulite 2000 xpi and an additiional positive shift of approximately 5% was observed with immulite 2000/ immulite 2000 xpi leading to the total positive shift of approximately 20%., two potential health risks:, 1. could mask uncontrolled acromegaly and thus affect patient treatment., 2. could lead to an under estimation of hgh deficiency in children with borderline hgh deficiency and potentially result in missed or delayed opportunity to treat with hgh supplement.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Immulite 2000/ Immulite 2000 xPi IGF-1

Manufacturer

Siemens Healthcare Diagnostics Products Limited
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    NZMMDSA