Events

Rappel de DIMENSION CLINICAL CHEMISTRY SYSTEM - ENZYMLE IICALIBRATOR (ENZ II CAL)

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
    80206
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-05-13
  • 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 received complaints of positive shift of patient and qc results when the alti assay is calibrated with specific lots of dimension enzyme ii calibrator. internal investigation has confirmed that patients quality control and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. the shift began with lot 4md047.

Device

DIMENSION CLINICAL CHEMISTRY SYSTEM - ENZYMLE IICALIBRATOR (ENZ II CAL)
  • Modèle / numéro de série
    Model Catalog: DC143 (Lot serial: 6AD054); Model Catalog: 10476170 (Lot serial: 4MD047); Model Catalog: DC143 (Lot serial: 5LD051); Model Catalog: 10476170 (Lot serial: 5LD051); Model Catalog: DC143 (Lot serial: 5JD069); Model Catalog: 10476170 (Lot serial: 5JD069); Model Catalog: DC143 (Lot serial: 5HD010); Model Catalog: 10476170 (Lot serial: 5HD010); Model Catalog: DC143 (Lot serial: 5GD050); Model Catalog: 10476170 (Lot serial: 5GD050); Model Catalog: DC143 (Lot serial: 5FD017); Model Catalog: 10476170 (Lot serial: 5FD017); Model Catalog: DC143 (Lot serial: 4MD047); Model Catalog: DC143 (Lot serial: 5CD052); Model Catalog: 10476170 (Lot serial: 5CD052); Model Catalog: 10476170 (Lot serial: 6AD054); Model Catalog: 10475527 (Lot serial: 5DD026); Model Catalog: KC321 (Lot serial: 5DD026); Model Catalog: 10475527 (Lot serial: 5LD061); Model Catalog: KC321 (Lot serial: 5LD061); Model Catalog: 10475527 (Lot serial: 5JD058); Model Catalog: KC321 (Lot serial: 5JD058); Model Catalog: 10475527 (Lot serial: 5GD004)
  • Description du dispositif
    DIMENSION CLINICAL CHEMISTRY SYSTEM- ENZYME II CALBIBRATOR (ENZ II CAL);DIMENSION XPAND SYSTEM-ENZYME II CALIBRATOR (ENZ II CAL);DIMENSION EXL SYSTEM-ENZYME II CALIBRATOR (ENZ II CAL);DIMENSION VISTA SYSTEM- ENZYME CALIBRATOR
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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