Events

Rappel de COULTER LH 500 HEMATOLOGY ANALYZER

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
    135614
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2011-11-03
  • 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
    Follows recall number 59046 (beckman coulter update letter dated april 20 2011 pca-14994). two additional lots of lh series pak reagent kits were not identified in the last communication. excess r flags and incomplete or abnormal differential computation results with use of coulter 5c cell control abnormal ii may also be encountered with lh series pak reagent kits lots 110882k and 110883k.

Device

COULTER LH 500 HEMATOLOGY ANALYZER
  • Modèle / numéro de série
    Model Catalog: 178833 (Lot serial: ALL); Model Catalog: 178832 (Lot serial: ALL); Model Catalog: A91062 (Lot serial: ALL); Model Catalog: A90994 (Lot serial: ALL); Model Catalog: 178834 (Lot serial: ALL); Model Catalog: 6605525 (Lot serial: ALL); Model Catalog: 6605524 (Lot serial: ALL); Model Catalog: 6605522 (Lot serial: ALL); Model Catalog: 6605526 (Lot serial: ALL); Model Catalog: 6605527 (Lot serial: ALL); Model Catalog: A85564 (Lot serial: ALL); Model Catalog: A85566 (Lot serial: ALL); Model Catalog: 6605523 (Lot serial: ALL); Model Catalog: 6706000 (Lot serial: ALL); Model Catalog: 6705999 (Lot serial: ALL); Model Catalog: 6705998 (Lot serial: ALL); Model Catalog: 6705997 (Lot serial: ALL); Model Catalog: 6705996 (Lot serial: ALL); Model Catalog: 6705995 (Lot serial: ALL); Model Catalog: 6604687 (Lot serial: ALL); Model Catalog: 6604569 (Lot serial: ALL)
  • Description du dispositif
    COULTER LH 500 SERIES ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.