Events

Retiro De Equipo (Recall) de AFFIRMAGEN 3 REAGENT RED BLOOD CELLS (POOLED CELLS)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ORTHO-CLINICAL DIAGNOSTICS.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57862
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-11-04
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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)
  • Modelo / Serial
    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
  • Descripción del producto
    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