Events

Rappel de CHECKCELLS (POOLED CELLS)

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

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
    60042
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-09-15
  • 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
    On sept. 14 2016 immucor inc. (manufacturer of the device) notified dominion biologicals limited of the intent to initiate a medical device recall on checkcell. immucor has received customer complaints of increased hemolysis seen in some vials of this lot. immucor's internal investigation has confirmed an increase in hemolysis in their remaining product inventory. immucor has performed additional serological testing on retention samples of lot 31864 and the reagent continues to meet reactivity specifications. immucor has indicated that testing results using this lot are valid provided the reagent meets the requirements for reactivity described in the quality control section of the package insert. the package insert also cautions the user that: antiglobulin control cells should not be used if the cells darken spontaneously clump or if there is significant hemolysis.

Device

CHECKCELLS (POOLED CELLS)
  • Modèle / numéro de série
    Model Catalog: 0002224 (Lot serial: 31864); Model Catalog: 0002225 (Lot serial: 31864)
  • Description du dispositif
    Checkcell
  • Manufacturer
    IMMUCOR INC.

Manufacturer

IMMUCOR INC.
  • Adresse du fabricant
    NORCROSS
  • Société-mère du fabricant (2017)
    Ivd Holdings Inc
  • Source
    HC