Events

Retiro De Equipo (Recall) de GALILEO NEO IMMUNO HAEMATOLOGY ANALYZER

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
    137314
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-12-11
  • 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
    Following the launch of the last software upgrade to neo install set 2.1 (aurora 2.09) there have been sporadic complaints in which results are not being received in the data management software (dms). users most commonly report that results are not visible in the results folder and/or do not print once processing is complete. when this occurs the user must intervene to try to resend the results to the dms or in many cases repeat the test. in this event the hazard is delay in reporting results. this issue has been linked to reuse of capture plate frames and users are advised to not use a plate frame more than 12 times.

Device

GALILEO NEO IMMUNO HAEMATOLOGY ANALYZER
  • Modelo / Serial
    Model Catalog: 0064599 (Lot serial: All serial numbers)
  • Descripción del producto
    Galileo NEO Automated Blood Bank System
  • Manufacturer
    IMMUCOR INC.

Manufacturer

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