Events

Retiro De Equipo (Recall) de CHECKCELLS (POOLED CELLS)

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

¿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
    60042
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-09-15
  • 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
    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)
  • Modelo / Serial
    Model Catalog: 0002224 (Lot serial: 31864); Model Catalog: 0002225 (Lot serial: 31864)
  • Descripción del producto
    Checkcell
  • Manufacturer
    IMMUCOR INC.

Manufacturer

IMMUCOR INC.
  • Dirección del fabricante
    NORCROSS
  • Empresa matriz del fabricante (2017)
    Ivd Holdings Inc
  • Source
    HC