Events

Retiro De Equipo (Recall) de IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottles

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Ltd Diagnostics Division.

¿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
    RC-2015-RN-00201-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00201-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics is conducting a correction for the immulite 2000 / immulite 2000 xpi immunoassay systems water and liquid waste bottles received from may 2013. siemens has identified that the water and liquid waste bottle assemblies were manufactured with a quality issue. the opening of both bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.This could result in the aspiration straw dislodging from the bottle causing the instrument to aspirate air into the fluidic line potentially resulting in discordant results.
  • Acción
    Siemens is providing work around instructions to assist end users to mitigate risk and identify faulty bottle openings. If a faulty bottle is identified end users are requested to contact Siemens for a replacement.

Device

IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottles
  • Modelo / Serial
    IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottlesSiemens Material Numbers: 10291586 and 10291587ARTG number: 174399
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA