Events

Rappel de IMMULITE 2000 and IMMULITE 2000 XPi

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Ltd Diagnostics Division.

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
    RC-2014-RN-01238-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01238-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    In december 2013, siemens healthcare diagnostics issued urgent recall for product correction (tga ref. rc-2014-rn-00002-1) for immulite 2000/immulite 2000 xpi androstenedione due to an observed over-recovery. during efforts to restore performance of the androstenedione assay it was confirmed that the issue noted in december 2013 was not limited to samples >5.5 ng/ml (>19.2 nmol/l). please refer to figures 1 and 2 for more information. the root cause of the over-recovery is related to the variability of a critical raw material.
  • Action
    Siemens is requesting their customers to discard the affected lot of IMMULITE 2000/IMMULITE 2000 XPi Androstenedione. A laboratory look back is recommended for any existing androstenedione sample(s) with values generated using the affected reagent lots during the period of time within sample stability labelling, and retesting using an alternate method. This action has been closed-out on 16/05/2017.

Device

IMMULITE 2000 and IMMULITE 2000 XPi
  • Modèle / numéro de série
    IMMULITE 2000 and IMMULITE 2000 XPi Catalogue number: SMN 10381188 Lot number: 314-323ARTG number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA