Events

Rappel de SPOT-LIGHT TISSUE PRETREATMENT KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par LIFE TECHNOLOGIES CORPORATION ALSO TRADING AS INVITROGEN CORPORATION.

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
    45565
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-11-14
  • 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
    Thermo fisher scientific received a customer complaint for spotlight tissue pretreatment kit (lot# 1714439a) which caused sample over-pepsinization. the investigation revealed four lots of spotlight tissue pretreatment kit contained an incorrectly formulated kit component (reagent 2). data entry errors made during the reagent 2 manufacturing process caused an incorrect amount of pepsin to be added to the component.

Device

SPOT-LIGHT TISSUE PRETREATMENT KIT
  • Modèle / numéro de série
    Model Catalog: 10190302000048 (Lot serial: 1667961A); Model Catalog: 10190302000048 (Lot serial: 1714439A); Model Catalog: 10190302000048 (Lot serial: 1763308A); Model Catalog: 10190302000048 (Lot serial: 1713166A)
  • Description du dispositif
    Spot-Light Tissue Pretreatment Kit
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION ALSO TRADING AS INVITROGEN CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION ALSO TRADING AS INVITROGEN CORPORATION