Events

Rappel de ADVIA CENTAUR XP SYSTEM - INSTRUMENT CLASS III

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
    129862
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-11-08
  • 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
    The wash interconnect circuit board on the advia centaur/advia centaur xp can fail due to contamination on the board during manufacturing and/or during use. when a failure occurs it is possible to have incorrect reporting of the wash1 sensors status. the fluid line of either sensor (s1 or s2) is reported to be empty when it is actually full or reported to be full when it is empty. these failures could either lead to the system not detecting an empty wash1 bottle or reservoir or stop the system from running due to a supposedly empty wash1 reservoir. if the sensors both fail in the "wet" state due to the board malfunction an erroneous but believable result may be released to the physician which is falsely high or low (depending on the assay architecture - competitive or sandwich).

Device

ADVIA CENTAUR XP SYSTEM - INSTRUMENT CLASS III
  • Modèle / numéro de série
    Model Catalog: 09066916 (Lot serial: ); Model Catalog: 078-A010-07 (Lot serial: ); Model Catalog: 04911855 (Lot serial: ); Model Catalog: 078-A001-14 (Lot serial: ); Model Catalog: 04911855 (Lot serial: >80 S/N CONTACT MANUFACTURER); Model Catalog: 078-A001-14 (Lot serial: >80 S/N CONTACT MANUFACTURER)
  • Description du dispositif
    ADVIA CENTAUR XP SYSTEM-INSTRUMENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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