Events

Rappel de MAS CARDIOIMMUNE XL MULTI-PACK

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par DIAGNOSTIX LTD.

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
    43343
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-12-20
  • 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
    Troponin i results in the cardioimmune xl control are measuring approximately 15-30% low in levels 1 and 3 resulting in control measurements which are outside the published value assignment ranges. as a precaution we are proactively recalling all levels associated with lot cxl1301. only troponin i control measurements are affected all other control analyte measurements are recovering within the published value assignment ranges. we are currently investigating the root cause.

Device

MAS CARDIOIMMUNE XL MULTI-PACK
  • Modèle / numéro de série
    Model Catalog: CAI-XL4 (Lot serial: CXL13014); Model Catalog: CAI-XL2 (Lot serial: CXL13013); Model Catalog: CAI-XL1 (Lot serial: CXL13013); Model Catalog: CAI-XL3 (Lot serial: CXL13012); Model Catalog: CAI-XL2 (Lot serial: CXL13012); Model Catalog: CAI-XL3 (Lot serial: CXL13011); Model Catalog: CAI-XL2 (Lot serial: CXL13011); Model Catalog: CAI-XL1 (Lot serial: CXL13011); Model Catalog: CAI-XL3 (Lot serial: CXL13013); Model Catalog: CAI-XL1 (Lot serial: CXL13012); Model Catalog: CAI-XLL (Lot serial: CXL1301L)
  • Description du dispositif
    MAS CARDIOIMMUNE XL MULTI-PACK
  • Manufacturer
    DIAGNOSTIX LTD

Manufacturer

DIAGNOSTIX LTD