Events

Rappel de Siemens Immulite GI-MA CA19-9

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
    18129
  • Date de mise en oeuvre de l'événement
    2015-02-20
  • 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 confirmed a positive bias with the bio-rad lyphochek® tumor marker plus control and the bio-rad liquichek™ tumor marker control when used with immulite® 2000/immulite® 2000 xpi gi-ma (ca 19-9) assay kit lots 312 and 313., in addition, a greater than expected change in patient sample recovery may be observed when moving from kit lot 311 to kit lots 312 and above., when comparing kit lot 312 with kit lot 311, siemens observed an average percent bias of 38% (ranging from 30% to 47%) for patient samples recovering from 29.6 to 44.4 u/ml and an average percent bias of 5% (ranging from 1% to 11%) for patient samples recovering from 540 to 660 u/ml., future kit lots are expected to recover quality control and patient samples similar to kit lot 312.
  • Action
    Instructions for use to be updated

Device

Siemens Immulite GI-MA CA19-9

Manufacturer

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