Events

Rappel de LEUKOSURE ENUMERATION KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECKMAN COULTER CANADA L.P..

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
    69169
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-06-07
  • 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
    There is incorrect activity levels stated on the instructions for use labeling in the leukosure enumeration kit due to the inaccurate activity values provided by the supplier for the raw material ribo-nuclease a type iii-a utilized as a component of the leukosure stain reagent. the activity value for these lots is 3.25ku/ml as compared to 4ku/ml as stated in the product labeling. alteration of the staining enumeration of white blood cells (wbc) in blood component preparation might produce falsely high values of white blood cells in samples with high levels of residual rna. these high values may result in the the blood component being considered inappropriate for use in transfusions thereby reducing the availability of blood for transfusion procedures. the high values may also result in unnecessary reprocessing of the blood component.

Device

LEUKOSURE ENUMERATION KIT
  • Modèle / numéro de série
    Model Catalog: 175621 (Lot serial: 5621013K); Model Catalog: 175621 (Lot serial: 5621012K); Model Catalog: 175621 (Lot serial: 5621014K)
  • Description du dispositif
    LEUKOSURE ENUMERATION KIT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.