Events

Rappel de ADVIA CENTAUR XP SYSTEM - CALIBRATORS

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
    21197
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-09-29
  • 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
    Calibrator e is used for calibration of the advia centaur systems cortisol progesterone and testosterone assays. siemens healthcare diagnostics has identified a positive bias for calibrator e kit lots ending in 38 and 39 with the advia centaur systems cortisol and progesterone assays compared to the respective master curves. patient serum samples evaluated with the advia centaur cortisol assay and calibrated with calibrator e kit lots listed in table 1 demonstrate an average positive bias of 16% across the assay range with a maximum bias of 28%. patient serum samples evaluated with the advia centaur systems progesterone assay and calibrated with calibrator e kit lots ending in 38 and 39 demonstrate a positive bias with samples above 30 ng/ml. the average positive bias on the advia centaur/advia centaur xp is 20% with a maximum bias of 39%. the average positive bias on the advia centaur cp is 17% with a maximum bias of 35%. the advia centaur systems testosterone assay is not affected by this correction.

Device

ADVIA CENTAUR XP SYSTEM - CALIBRATORS
  • Modèle / numéro de série
    Model Catalog: 04634762 (Lot serial: >10 contact mfg.); Model Catalog: 04634452 (Lot serial: >10 contact mfg.); Model Catalog: 04636889 (Lot serial: >10 contact mfg.)
  • Description du dispositif
    Advia Centaur XP System - Calibrator E
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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