Events

Rappel de ADVIA CENTAUR SYSTEM - FOLATE ASSAY

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
    145765
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-11-07
  • 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 advia centaur assays listed above show changes in patient samples and quality control values when the ambient temperature of the room or laboratory shifts between 18 c - 30 c where the advia centaur system is installed. these assays are not meeting the specifications within the operating temperature range which is 18 c - 30 c. this effect occurs on either the advia centaur advia centaur xp and/or advia centaur cp systems depending on the assay and the system.

Device

ADVIA CENTAUR SYSTEM - FOLATE ASSAY
  • Modèle / numéro de série
    Model Catalog: 06891541 (Lot serial: ); Model Catalog: 02816138 (Lot serial: ); Model Catalog: 06367974 (Lot serial: ALL LOTS FOR ALL DEVICES); Model Catalog: 06891541 (Lot serial: ALL LOTS FOR ALL DEVICES); Model Catalog: 02419937 (Lot serial: ); Model Catalog: 03896216 (Lot serial: ); Model Catalog: 03204829 (Lot serial: ); Model Catalog: 01157807 (Lot serial: ); Model Catalog: 02816634 (Lot serial: ); Model Catalog: 06489701 (Lot serial: ); Model Catalog: 04612750 (Lot serial: ); Model Catalog: 03481938 (Lot serial: ); Model Catalog: 10491379 (Lot serial: ); Model Catalog: 10491244 (Lot serial: ); Model Catalog: 03009619 (Lot serial: ); Model Catalog: 08838753 (Lot serial: ); Model Catalog: 06367974 (Lot serial: ); Model Catalog: 09046419 (Lot serial: ); Model Catalog: 08861968 (Lot serial: ); Model Catalog: 10378883 (Lot serial: )
  • Description du dispositif
    ADVIA CENTAUR FOLATE (FOL) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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