Events

Rappel de ADVIA CENTAUR CP SYSTEM - CALIBRATOR

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
    132703
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-02-16
  • 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 a lot to lot bias with calibrator e kit for the advia centaur testosterone assay. internal investigation demonstrates: -an average positive bias of 17% across the assay range with calibrator e kit lots ending in 42 as compared to values generated with the master curve. -an average negative bias of 7% across the assay range with calibrator e kit lots ending in 43 as compared to values generated with the master curve. -the positive bias of calibrator e kit lots ending in 42 to the master curve compared to the negative bias of calibrator e kit lots ending in 43 to the master curve is the main driver for the negative bias between values generated with calibrator e kit lots ending in 42 and calibrator e kit lots ending in 43. the bias of the calibrators to the master curve has been corrected with calibrator e kit lots ending in 44. the performance of the testosterone assay on the advia centaur cp is not affected. calibrator e is also used for calibration of the advia centaur systems cortisol and progesterone assays however the performance of these assays is not affected.

Device

ADVIA CENTAUR CP SYSTEM - CALIBRATOR
  • Modèle / numéro de série
    Model Catalog: 04636889 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 04634762 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 04634452 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Description du dispositif
    ADVIA CENTAUR CP SYSTEM-CALIBRATOR;ADVIA CENTAUR SYSTEM-CALIBRATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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