Events

Rappel de ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD

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
    146351
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2018-03-05
  • 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 there is a potential for incorrect settings to be installed on north american ichemvelocity urine chemistry analyzers. - the installation of international settings can result in the generation of erroneous false low results for some of the analytes at some concentrations. - the installation of colors different from those stated in the instructions for use (colorless straw yellow amber red blue) for output settings will result in incorrect reporting of colors. for example if green is the color choice for the output setting instead of blue green will be reported.

Device

ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD
  • Modèle / numéro de série
    Model Catalog: 800-7167 (Lot serial: ALL); Model Catalog: 800-7714 (Lot serial: ALL); Model Catalog: 800-7713 (Lot serial: ALL); Model Catalog: 800-3079 (Lot serial: ALL); Model Catalog: 800-7720 (Lot serial: ALL); Model Catalog: 800-3049 (Lot serial: ALL); Model Catalog: 800-7719 (Lot serial: ALL); Model Catalog: 800-7715 (Lot serial: ALL); Model Catalog: 800-3080 (Lot serial: ALL); Model Catalog: 800-3050 (Lot serial: ALL)
  • Description du dispositif
    ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD;IRICELL 2000 PLUS;IRICELL 3000 PLUS;ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM BACK INTEGRATED;IRICELL 2000 PRO;ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM;IRICELL 1000 PLUS;IRICELL 30
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.