Events

Rappel de Siemens Advia Centaur XPT

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 Inc.

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
    18951
  • Date de mise en oeuvre de l'événement
    2015-08-03
  • 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, 55 Hugo Johnston Drive, Penrose, Auckland
  • Cause
    Siemens healthcare diagnostics has identified multiple issues with the advia centaur® xpt system software v1.0.1 (bundle 1.0.912 smn 10819704) and v1.0.2 (bundle 1.0.1086 smn 11219806)., when running thcg samples with an initial dilution of 1 to 200, without processing neat specimens, it is potentially possible to miss a positive thcg value where the neat value is less than 1000. a lookback of 48 hours is recommended for negative thcg samples if neat values were not initially run for thcg and large dilutions were employed., there is the extremely unlikely potenial to transpose patient results when running in rack order mode without positive sample identificiation., similarly a lookback of 48 hours for any instruments running in this mode is recommended.
  • Action
    Software to be upgraded

Device

Siemens Advia Centaur XPT

Manufacturer

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