Events

Rappel de STACLOT LA 20 IVD REAGENT

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

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
    135267
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-02-04
  • 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
    Internal investigations have determined that certain lots of the roduct were marketed in canada utilizing the incorrect reference number and consequently without proper registration with health canada (unlicenced device). however there is an equivalent product utilizing a different reference that is properly registered with health canada. there is no functional difference between the two product reference numbers with the exception of the number of tests that can be conducted.

Device

STACLOT LA 20 IVD REAGENT
  • Modèle / numéro de série
    Model Catalog: 0594 (Lot serial: 104679); Model Catalog: 0594 (Lot serial: 104449); Model Catalog: 0594 (Lot serial: 102788); Model Catalog: 58230 (Lot serial: 8047402); Model Catalog: 58230 (Lot serial: 7086966); Model Catalog: 58230 (Lot serial: 7117121); Model Catalog: 58230 (Lot serial: 8047411); Model Catalog: 58230 (Lot serial: 8027323); Model Catalog: 58230 (Lot serial: 8027328); Model Catalog: 58230 (Lot serial: 8047404); Model Catalog: 58230 (Lot serial: 8027325); Model Catalog: 58230 (Lot serial: 8047409); Model Catalog: 58230 (Lot serial: 8047401); Model Catalog: 58230 (Lot serial: 8017261); Model Catalog: 58230 (Lot serial: 8027317); Model Catalog: 58230 (Lot serial: 7086963)
  • Description du dispositif
    STACLOT LA 20
  • Manufacturer
    STAGO CANADA LTD./STAGO CANADA LTEE

Manufacturer

STAGO CANADA LTD./STAGO CANADA LTEE