Events

Rappel de BOND READY-TO-USE PRIMARY ANTIBODY ALPHA-METHYLACYL-COA RACEMASE (EPMUI)

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
    69955
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-12-29
  • 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
    These antibodies and probes when used in combination with specified lots of the bond polymer refine detection and novolink polymer detection system may not provide adequate staining when used according to the instructions for use. if the products are used according to their instructions for use with appropriate positive controls the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of ihc / ish staining and in a worst-case scenario could cause a delay in the diagnosis or classification of a neoplasm.

Device

BOND READY-TO-USE PRIMARY ANTIBODY ALPHA-METHYLACYL-COA RACEMASE (EPMUI)
  • Modèle / numéro de série
    Model Catalog: PA0210 (Lot serial: all lots); Model Catalog: PB0645 (Lot serial: all lots); Model Catalog: PB0669 (Lot serial: all lots); Model Catalog: PB0785 (Lot serial: all lots); Model Catalog: PA0552 (Lot serial: all lots); Model Catalog: PB0614 (Lot serial: all lots); Model Catalog: PB0809 (Lot serial: all lots); Model Catalog: PB0589 (Lot serial: all lots); Model Catalog: NCL-L-AMACR (Lot serial: all lots)
  • Description du dispositif
    BOND READY-TO-USE PRIMARY ANTIBODY ALPHA-METHYLACYL-COA RACEMASE (EPMU1)
  • Manufacturer
    LEICA MICROSYSTEMS INC.

Manufacturer

LEICA MICROSYSTEMS INC.