Events

Retiro De Equipo (Recall) de IMMULITE SYSTEM - FOLICAL STIMULATING HORMONE (FSH) 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
    25667
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-10-17
  • 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
    An internal complaint identified a barcode conflict between immulite/immulite 1000 follicle- stimulating hormone (fsh) lkfs reagent wedge lots 351 and 352 where both reagent wedge lots were displayed by the software as lot '01'. this could result in the incorrect reagent wedge lot being used for a kit lot if both reagent wedges were on the instrument at the same time. an internal investigation concluded that there would be no impact to patient or quality control results if reagent wedges were mis-matched. customer complaint escalations identified "adjustment overdue" or "expired" flags when immulite /immulite 1000 fsh reagent lot 351 was stored in system history and reagent lot 352 was introduced to the system. the customer (field) confirmed "adjustment overdue" or "expired" flags could not be replicated internally. note: kit lot 351 expired august 31 2014 kit lot 352 expires october 31 2014.

Device

IMMULITE SYSTEM - FOLICAL STIMULATING HORMONE (FSH) ASSAY
  • Modelo / Serial
    Model Catalog: LKFS1 (Lot serial: 352); Model Catalog: LKFS1 (Lot serial: 351)
  • Descripción del producto
    IMMULITE SYSTEM - FOLICAL STIMULATING HORMONE (FSH) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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