Events

Rappel de Siemens Centaur Tnl Ultra

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
    18574
  • Date de mise en oeuvre de l'événement
    2015-05-22
  • 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
    Siemens healthcare diagnostics has observed a system-to-system bias between the tni-ultra™ assay on the advia centaur® cp and advia centaur/advia centaur xp/advia centaur xpt systems with the advia centaur cp generating lower results than the advia centaur/advia centaur xp/advia centaur xpt system. siemens is actively pursuing the cause of this issue., this observation impacts customers who use the tni-ultra assay on both the advia centaur cp and advia centaur/advia centaur xp/advia centaur xpt systems interchangeably when interpreting serial testing in patient samples. this communication does not impact customers who use tni-ultra results solely from either the advia centaur/advia centaur xp/advia centaur xpt system or the advia centaur cp system.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Centaur Tnl Ultra
  • Modèle / numéro de série
    Model: SMN: 10317708 (100 test kit), 10317709 (500 test kit), Affected: Kit Lots ending in 088, 089, 090, 091, 093 and 094 and all future lots until the issue is resolved and a follow-up communication is issued
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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