Events

Retiro De Equipo (Recall) de VersaCell connected to IMMULITE 2000/IMMULITE 2000 XPi analysers

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-2014-RN-00137-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-07
  • 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-2014-RN-00137-1
  • 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
    There is a potential for incorrect results to be reported when the versacell system drops a sample tube during transfer to the immulite 2000/immulite 2000 xpi automation rack under certain specific conditions. this issue only occurs with versacell systems that are connected to immulite 2000/2000xpi and does not affect any other analysers that interface with the versacell system.
  • Acción
    Siemens is providing additional instructions to mitigate the occurrence of incorrect results due to dropped tubes. Investigations into the issue are continuing and customers will be alerted once a solution has been developed. This action has been closed-out on 04/04/2017.

Device

VersaCell connected to IMMULITE 2000/IMMULITE 2000 XPi analysers

Manufacturer

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