Events

Rappel de IMMULITE SYSTEM - ANTI-TG AB

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SIEMENS HEALTHCARE 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
    64415
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-03-24
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Siemens healthcare diagnostics has confirmed that the intra-assay and inter-assay precision of the immulite/immulite 1000 and immulite immulite 2000 xpi anti-tg ab assays does not align with the representative data published in the instructions for use (ifu). siemens has conducted a "verification of precision performance" study to assess precision. while the concentrations did not exactly match those published in the ifu the study provides verification that the current precision performance is not in line with the ifu.

Device

IMMULITE SYSTEM - ANTI-TG AB
  • Modèle / numéro de série
    Model Catalog: LKTG1 (Lot serial: 244); Model Catalog: L2KTG6 (Lot serial: 567); Model Catalog: L2KTG2 (Lot serial: 567); Model Catalog: L2KTG6 (Lot serial: 565); Model Catalog: L2KTG2 (Lot serial: 565); Model Catalog: L2KTG6 (Lot serial: 560); Model Catalog: L2KTG2 (Lot serial: 560); Model Catalog: L2KTG6 (Lot serial: 577); Model Catalog: L2KTG2 (Lot serial: 577); Model Catalog: L2KTG6 (Lot serial: 574); Model Catalog: L2KTG2 (Lot serial: 574); Model Catalog: L2KTG6 (Lot serial: 572); Model Catalog: L2KTG2 (Lot serial: 572); Model Catalog: L2KTG6 (Lot serial: 569); Model Catalog: L2KTG2 (Lot serial: 569); Model Catalog: L2KTG6 (Lot serial: 562); Model Catalog: L2KTG2 (Lot serial: 562); Model Catalog: L2KTG6 (Lot serial: 566); Model Catalog: L2KTG2 (Lot serial: 566); Model Catalog: L2KTG6 (Lot serial: 564); Model Catalog: L2KTG2 (Lot serial: 564); Model Catalog: LKTG1 (Lot serial: 245)
  • Description du dispositif
    Immulite System-Anti-TG AB
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC