Events

Rappel de ADVIA CENTAUR CP SYSTEM - FOLATE (FOL) 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
    43802
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-03-26
  • 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 confirmed one set of complaints with the advia centaur systems folate kit lots ending in 223. customers observed that the bio-rad liquichek and lyphochek folate serum controls may go out of range low with advia centaur systems folate kit lots ending in 223. whole blood controls with advia centaur folate reagent kit lots ending in 223 are within range and whole blood patients are consistent with previous reagent lots. in addition siemens has confirmed a second set of customer complaints regarding a shift in whole blood patients when moving from advia centaur systems folate kit lots ending in 219 to kit lots ending in 222224 225 226 and/or 227. siemens performed a whole blood normal range study that shows kit lots ending in 219 do not demonstrate a normal range pattern shown in the instructions for use (ifu). serum controls and patients show normal lot to lot variation with all in date lots of folate reagents.

Device

ADVIA CENTAUR CP SYSTEM - FOLATE (FOL) ASSAY
  • Modèle / numéro de série
    Model Catalog: 131096 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 06891541 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 124838 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 06367974 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 118551 (Lot serial: 226227 FOR ALL DEVICES); Model Catalog: 126638 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 131096 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 06891541 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 124838 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 06367974 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 118551 (Lot serial: LOTS ENDING IN 219222224225); Model Catalog: 126638 (Lot serial: 226227 FOR ALL DEVICES)
  • Description du dispositif
    ADVIA CENTAUR CP SYSTEM - FOLATE (FOL) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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