Events

Rappel de VYSIS PARAFFIN PRETREATMENT KIT

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

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
    115112
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-10-26
  • 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
    It was recently identified that some vysis paraffin pretreatment reagent kits may have been distributed with an incorrect lot number printed on the packaging labeling. the kit lot number appears in three places on the vysis paraffin pretreatment reagent kits: 1. the abbott molecular certificate of analysis that is packed within each kit 2. the label which is placed on the kit carton and 3. the label which is placed on the outer sleeve that goes over the kit carton. the correct lot number is 2087c172 and it is correctly printed on the certificate of analysis that is packaged within each kit. although unlikely an incorrect lot number (2347c384) may have been printed on the kit carton label and/or on the outer sleeve label.

Device

VYSIS PARAFFIN PRETREATMENT KIT
  • Modèle / numéro de série
    Model Catalog: 02J02-032 (Lot serial: 2087C172)
  • Description du dispositif
    VYSIS PARAFFIN PRETREATMENT KIT
  • Manufacturer
    INTER MEDICO

Manufacturer

INTER MEDICO
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Inter Medico
  • Source
    HC