Events

Rappel de LAMININ AB-1 100UL

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

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
    72976
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-10-21
  • 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
    During a recent internal review of medical devices it was discovered that two ivd antibodies from lab vision were loaded into our system as class i medical device which is sold and classified in the united states as class i.The lab vision antibodies which are classified as ivd (in vitro diagnosis) are classified as medical device class ii in canada. since it was downloaded from the us system as class i medical device it was not being verified against health canada medical device licensing at the time.

Device

LAMININ AB-1 100UL
  • Modèle / numéro de série
    Model Catalog: TA015BB (Lot serial: NA); Model Catalog: RB082A0 (Lot serial: NA)
  • Description du dispositif
    LAMININ AB-1 100UL
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC