Events

Rappel de INSTRUMENT MANAGER

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
    23543
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-03-08
  • 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
    Importing error code mapping into instrument manager (im) v.8.12.10 and higher may clear another configuration's error code mapping. results that should be flagged from that configuration will not be flagged and have no result error codes. rules that evaluate error code(s) may also be affected. per data innovations: the absence of result flags and error codes compromises result evaluation and handling. medical decisions based on these potentially erroneous results can lead to patient harm.

Device

INSTRUMENT MANAGER
  • Modèle / numéro de série
    Model Catalog: VX.XX (Lot serial: software-no lot numbers); Model Catalog: 8.14.01 (Lot serial: software-no lot numbers); Model Catalog: 8.14.00 (Lot serial: software-no lot numbers); Model Catalog: 8.13.04 (Lot serial: software-no lot numbers); Model Catalog: 8.13.03 (Lot serial: software-no lot numbers); Model Catalog: 8.13.02 (Lot serial: software-no lot numbers); Model Catalog: 8.13.01 (Lot serial: software-no lot numbers); Model Catalog: 8.13.00 (Lot serial: software-no lot numbers); Model Catalog: 8.12.22 (Lot serial: software-no lot numbers); Model Catalog: 8.12.21 (Lot serial: software-no lot numbers); Model Catalog: 8.12.20 (Lot serial: software-no lot numbers); Model Catalog: 8.12.12 (Lot serial: software-no lot numbers); Model Catalog: 8.12.11 (Lot serial: software-no lot numbers); Model Catalog: 8.12.10 (Lot serial: software-no lot numbers); Model Catalog: VX.XX (Lot serial: N/A); Model Catalog: 8.14.01 (Lot serial: N/A); Model Catalog: 8.14.00 (Lot serial: N/A); Model Catalog: 8.13.04 (Lot seria
  • Description du dispositif
    DATA INNOVATIONS INSTRUMENT MANAGER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.