Events

Rappel de AFFIRMAGEN 3 REAGENT RED BLOOD CELLS (POOLED CELLS)

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

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
    57862
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-11-04
  • 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
    Ortho clinical diagnostics (ortho) has initiated this recall because ortho has received an increase in customer complaints and has confirmed the intermittent presence of marked hemolysis in ortho reagent red blood cell (rrbc) products as well as quality control products containing red blood cells. ortho conducted an extensive investigation and the root cause for the marked hemolysis has been identified as microbial contamination.

Device

AFFIRMAGEN 3 REAGENT RED BLOOD CELLS (POOLED CELLS)
  • Modèle / numéro de série
    Model Catalog: 719211 (Lot serial: 83A291); Model Catalog: 719211 (Lot serial: 83A290); Model Catalog: 719201 (Lot serial: > 10 CONTACT MANUFACTURER); Model Catalog: 719211 (Lot serial: 83A289); Model Catalog: 6902319 (Lot serial: VRC225); Model Catalog: 6902319 (Lot serial: VRC223); Model Catalog: 6902319 (Lot serial: VRC226); Model Catalog: 719810 (Lot serial: > 10 contact manufacturer); Model Catalog: 6902319 (Lot serial: VRC224); Model Catalog: 719100 (Lot serial: > 10 contact manufacturer); Model Catalog: 6902314 (Lot serial: VP226); Model Catalog: 6902314 (Lot serial: VP225); Model Catalog: 6902314 (Lot serial: VP224); Model Catalog: 719520 (Lot serial: RB451); Model Catalog: 719520 (Lot serial: RB458); Model Catalog: 719520 (Lot serial: RB453); Model Catalog: 719520 (Lot serial: RB455); Model Catalog: 719520 (Lot serial: RB456); Model Catalog: 719520 (Lot serial: RB457); Model Catalog: 719520 (Lot serial: RB452); Model Catalog: 6902317 (Lot serial: VRA260); Model Catalog: 6902316 (Lot serial: > 10 con
  • Description du dispositif
    Reagent Red Blood Cells 0.8% AFFIRMAGEN 3;Reagent Red Blood Cells 0.8% AFFIRMAGEN;Reagent Red Blood Cells 0.8% Resolve Panel C System;Reagent Red Blood Cells (Pooled Cells) Ortho Coombs Control;Reagent Red Blood Cells Surgiscreen;Reagent Red Blood Cells O
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS