Events

Rappel de Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. An in vitro diagnostic medical device (IVD)

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-2012-RN-01174-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-21
  • 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-2012-RN-01174-1
  • 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
    The manufacturer confirms a positive shift in patient medians of approximately 20% with the igf-1 assay. the manufacturer advises that the performance of kit lots currently in distribution is in alignment with the medians of the reference data range published in instructions for use. additionally, siemens wants to notify customers of an upcoming major supply disruption.
  • Action
    Laboratories to implement the work-around provided by the sponsor. A review of previously reported results should be considered.

Device

Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. An in vitro diagn...
  • Modèle / numéro de série
    Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. An in vitro diagnostic medical device (IVD)Immulite / Immulite 1000 XPi IGF-1Catalogue Number: L2KGFSiemens Material Number: 10381448Lot Number: 441-492Immulite 2000 / Immulite 2000 XPi IGF-1Catalogue Number: LKGF1Siemens Material Number: 10381403Lot Number: 315-334ARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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