Events

Retiro De Equipo (Recall) de CAPILLARY CAPS

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
    121751
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-01-27
  • 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 receipt of customer complaints an investigation identified that a material change made by the supplier has resulted in capillary caps that are more difficult to apply to the capillaries. attempting to apply these capillary caps to the capillaries could result in spillage of the sample or possible breakage of the glass capillary. siemens is advising customers to use caution when applying the capillary caps with siemens multicap glass and multicap-s plastic capillaries to minimize the potential for breakage or bending.

Device

CAPILLARY CAPS
  • Modelo / Serial
    Model Catalog: 10311053 (Lot serial: ALL LOTS MADE AFTER APRIL 2013); Model Catalog: 10311054 (Lot serial: ALL LOTS MADE AFTER APRIL 2013); Model Catalog: 10328655 (Lot serial: ALL LOTS MADE AFTER APRIL 2013)
  • Descripción del producto
    CAPS FOR CAPILLARY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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