Events

Rappel de DXH 500

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
    144731
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-11-07
  • 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
    Beckman coulter has determined that if the bleach cycle is interrupted or aborted the dxh 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis. should a bleach cycle get interrupted the subsequent software recovery to perform a diluter reset may not be sufficient to prevent the first immediate sample run from being affected. patient results may be impacted due to residual bleach in the diluter when a sample is processed immediately after a bleach cycle is interrupted.

Device

DXH 500
  • Modèle / numéro de série
    Model Catalog: B40601 (Lot serial: AZ120651); Model Catalog: B40601 (Lot serial: AZ120636); Model Catalog: B40601 (Lot serial: BA070451); Model Catalog: B40601 (Lot serial: BA060399); Model Catalog: B40601 (Lot serial: AZ120657); Model Catalog: B40601 (Lot serial: AZ120656); Model Catalog: B40601 (Lot serial: AZ120655); Model Catalog: B40601 (Lot serial: AZ110582); Model Catalog: B40601 (Lot serial: BA070450); Model Catalog: B40601 (Lot serial: AZ060306); Model Catalog: B40601 (Lot serial: 1.0.2 and 1.1); Model Catalog: B40601 (Lot serial: AZ030171); Model Catalog: B40601 (Lot serial: BA060398)
  • Description du dispositif
    DXH 500 OPEN-VIAL HEMATOLOGY SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.