Events

Rappel de BBL LYSINE IRON AGAR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECTON DICKINSON CANADA 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
    17117
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-01-16
  • 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
    The ph is at 6.2 to 6.3 versus a specification of 6.5 to 6.9. the material contains a ph indicator (bromcresol purple) which is used as part of the mechanism of differentiation. the low ph is causing organisms that should give alkaline reactions to not give the correct reaction two complaints originating in the us (dec 2010 and june 2011) have been filed with the manufacturer in regards to failed ph results. both facilities properly prepared the medium and both found inconsistent performance based on quality control specifications. however proper qc was performed leading the facilities to not use the product.

Device

BBL LYSINE IRON AGAR
  • Modèle / numéro de série
    Model Catalog: 211363 (Lot serial: 0238264); Model Catalog: 211363 (Lot serial: 0204203); Model Catalog: 211363 (Lot serial: 0132356)
  • Description du dispositif
    BBL Lysine Iron Agar
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.