Events

Rappel de ADVIA CENTAUR 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
    25695
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-01-12
  • 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 negative bias for advia centaur ft4 when used with calibrator a kit lots ending in 90 on the advia centaur advia centaur xp and advia centaur xpt systems. in addition siemens healthcare diagnostics confirmed the potential for calibration failures due to above limit calibrator rlu %cvs when using calibrator a kit lots ending in 90 with the ft4 assay. the performance of the ft4 assay when used with calibrator a kit lots ending in 90 on the advia centaur cp system is not affected. customers may continue to use calibrator a kit lots ending in 90 for the advia centaur systems ft3 t3 t4 and tup assays. internal investigations were performed using available ft4 lots. the investigation confirmed an overall negative bias when comparing calibrator a kit lots ending in 90 to previously released calibrator a kit lots ending in 89. in some instances the negative bias may cause euthyroid patient samples to result low and outside the reference interval listed in the instructions for use (ifu). quality control material and master curve material may result low and outside acceptable ranges.

Device

ADVIA CENTAUR SYSTEM - CALIBRATORS
  • Modèle / numéro de série
    Model Catalog: 04800735 (Lot serial: >10 LOT NUMBERS CONTACT MFR); Model Catalog: 04800646 (Lot serial: >10 LOT NUMBERS CONTACT MFR)
  • Description du dispositif
    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