Events

Rappel de ENVISION + SYSTEM/HRP RABBIT (DAB+)

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

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
    67277
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2005-11-28
  • 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
    A formulation error has occurred in the envision visualization reagent. when used quantitatively it will result in a reduction in intensity potentially leading to inappropriate exclusion for treatment.

Device

ENVISION + SYSTEM/HRP RABBIT (DAB+)
  • Modèle / numéro de série
    Model Catalog: K4011 (Lot serial: 075115); Model Catalog: K4009 (Lot serial: 065144); Model Catalog: K4011 (Lot serial: 055032); Model Catalog: K4010 (Lot serial: 055032); Model Catalog: K4011 (Lot serial: 035196); Model Catalog: K4010 (Lot serial: 035196); Model Catalog: K4011 (Lot serial: 075114); Model Catalog: K4010 (Lot serial: 075114); Model Catalog: K4011 (Lot serial: 055031); Model Catalog: K4010 (Lot serial: 055031); Model Catalog: K4011 (Lot serial: 035293); Model Catalog: K4010 (Lot serial: 035293); Model Catalog: K4007 (Lot serial: 075113); Model Catalog: K4006 (Lot serial: 075113); Model Catalog: K4007 (Lot serial: 045173); Model Catalog: K4006 (Lot serial: 045173); Model Catalog: K4007 (Lot serial: 075112); Model Catalog: K4006 (Lot serial: 075112); Model Catalog: K4007 (Lot serial: 045172); Model Catalog: K4006 (Lot serial: 045172); Model Catalog: K4002 (Lot serial: 065139); Model Catalog: K4003 (Lot serial: 045037); Model Catalog: K4002 (Lot serial: 045037); Model Catalog: K4000 (Lot serial:
  • Description du dispositif
    Envision+System/HRP (DAB+)
  • Manufacturer
    OXOID (ELY) LIMITED

Manufacturer

OXOID (ELY) LIMITED
  • Adresse du fabricant
    ELY
  • Source
    HC