Events

Rappel de LEICA PELORIS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par LEICA MICROSYSTEMS INC..

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
    29078
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-02-11
  • 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
    1. if during a manual bottle change the reset button is pressed with out actually changing the reagent the instrument will interpret the reset as fresh reagent being loaded and then use the reagent in the final tissue-processing step. the use of a degraded reagent in the final processing step can cause or contribute to tissue becoming unfit for diagnosis and if additional tissue is unavailable a rebiopsy may be required. 2. if a non-validated protocol is used or validated protocol is used inappropiately (i.E. wrong tissue sizetype or duration) this can cause or contribute to tissue becoming unfit for diagnosis and if additional tissue is unavailable a re-biopsy may be required.

Device

LEICA PELORIS
  • Modèle / numéro de série
    Model Catalog: 26.0001 (Lot serial: 0260095B); Model Catalog: 26.0001 (Lot serial: 0260097B); Model Catalog: 26.0001 (Lot serial: 0260109B); Model Catalog: 26.0001 (Lot serial: 0260114B); Model Catalog: 26.0001 (Lot serial: 0260118B); Model Catalog: 26.0001 (Lot serial: 0260144B); Model Catalog: 26.0001 (Lot serial: 0260163B); Model Catalog: 26.0001 (Lot serial: 0260178B); Model Catalog: 26.0001 (Lot serial: 0260190B); Model Catalog: 26.0001 (Lot serial: 0260295B); Model Catalog: 26.0001 (Lot serial: 0260035B); Model Catalog: 26.0001 (Lot serial: 0260043B); Model Catalog: 26.0001 (Lot serial: 0260009B); Model Catalog: 26.0001 (Lot serial: 0260300B); Model Catalog: 26.0001 (Lot serial: 0260038B)
  • Description du dispositif
    LEICA PELORIS RAPID TISSUE PROCESSOR
  • Manufacturer
    LEICA MICROSYSTEMS INC.

Manufacturer

LEICA MICROSYSTEMS INC.