Events

Retiro De Equipo (Recall) de IMMULITE 2000 SYSTEM - GI-MA ASSAY

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

¿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
    18668
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-02-13
  • 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
    Siemens healthcare diagnostics has confirmed a positive bias with the bio-rad lyphochek tumor marker plus control and the bio-rad liquichek tumor marker control when used with immulite 2000/immulite 2000 xpi gi-ma (ca19-9) assay kit lots 312 and 313. in addition a greater than expected change in patient sample recovery may be observed when moving from kit lot 311 to kit lots 312 and above. while recovery with patient samples for individual kit lots continues to meet siemens quality control release specification kit lot 311 was observed to perform at the lower end of the specification and kit lot 312 at the upper end of the specification resulting in a greater than expected difference between these two kit lots.

Device

IMMULITE 2000 SYSTEM - GI-MA ASSAY
  • Modelo / Serial
    Model Catalog: L2KGI2 (Lot serial: LOTS 312 AND 313)
  • Descripción del producto
    IMMULITE 2000 SYSTEM - GI-MA ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC