Events

Rappel de HISTOPAQUE 1077-1

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SIGMA-ALDRICH CANADA CO..

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
    74172
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2009-12-31
  • 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
    This corrective action was to revise the instructions for use to recommend to the end user to sterile filter histopaque prior to use if separated cells will be subsequently cultured or if sterility is a requirement for down stream use of the cells. this action resulted in a recall to notify any recipients of in-vitro diagnostic labelled histopaque batches still within their expiry dates as of november of 2009 of this change to the instructions for use.

Device

HISTOPAQUE 1077-1
  • Modèle / numéro de série
    Model Catalog: 10771-500ML (Lot serial: 087K6015); Model Catalog: 10771-6X100ML (Lot serial: 069K6086); Model Catalog: 10771-100ML (Lot serial: 069K6086); Model Catalog: 10771-500ML (Lot serial: 069K6086); Model Catalog: 10771-6X100ML (Lot serial: 047K6015); Model Catalog: 10771-100ML (Lot serial: 047K6015); Model Catalog: 10771-500ML (Lot serial: 047K6015); Model Catalog: 10771-6X100ML (Lot serial: 037K6141); Model Catalog: 10771-100ML (Lot serial: 037K6141); Model Catalog: 10771-500ML (Lot serial: 037K6141); Model Catalog: 10771-6X100ML (Lot serial: 107K6201); Model Catalog: 10771-100ML (Lot serial: 107K6201); Model Catalog: 10771-500ML (Lot serial: 107K6201); Model Catalog: 10771-6X100ML (Lot serial: 088K6035); Model Catalog: 10771-100ML (Lot serial: 088K6035); Model Catalog: 10771-500ML (Lot serial: 088K6035); Model Catalog: 10771-6X100ML (Lot serial: 037K6300); Model Catalog: 10771-100ML (Lot serial: 037K6300); Model Catalog: 10771-500ML (Lot serial: 037K6300); Model Catalog: 10771-6X100ML (Lot serial:
  • Description du dispositif
    HISTOPAQUE 1077-1
  • Manufacturer
    SIGMA-ALDRICH CANADA CO.

Manufacturer

SIGMA-ALDRICH CANADA CO.
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Merck KGaA
  • Source
    HC