Events

Rappel de Siemens Immulite Androstenedione

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
    15975
  • Date de mise en oeuvre de l'événement
    2014-01-06
  • 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 over-recovery of samples with concentrations greater than 5.5 ng/ml (19.2 nmol/l) with the immulite/immulite 1000 and immulite 2000/immulite 2000 xpi androstenedione assays (lkao1, l2kao2)., siemens has determined that these lots are linear up to a concentration of 5.5 ng/ml (19.2 nmol/l), instead of 10 ng/ml (34.9 nmol/l) as stated in the instructions for use (ifu). quality control materials at concentrations between 5.5 ng/ml (19.2 nmol/l) and 10 ng/ml (34.9 nmol/l) will detect this issue.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Immulite Androstenedione

Manufacturer

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