Events

Rappel de DURACLONE B27 REAGENT KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECKMAN COULTER CANADA L.P..

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
    20667
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-05-03
  • 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
    Beckman coulter has identified that the reagent lot identified above was inadvertently released to market despite not meeting its full product specification. the hla-b27 median fluorescence intensity (mdfi) of this lot is higher than lots meeting the product specification which may lead to: (1) an indicated result in the indeterminate zone when the true result is in the negative range or (2) an indicated result in the positive range when the true result is in the indeterminate zone. the issue was discovered on 2016 march 21 during periodic review of our batch records. there has been no report of death or injury related to this defect.

Device

DURACLONE B27 REAGENT KIT
  • Modèle / numéro de série
    Model Catalog: B36862 (Lot serial: 210116)
  • Description du dispositif
    DURACLONE B27
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.