Events

Retiro De Equipo (Recall) de Phenobarbitol Reagent (used with ADVIA Chemistry System). An in vitro diagnostic medical device (IVD)

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-2012-RN-01179-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-28
  • 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-2012-RN-01179-1
  • 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
    Internal studies have indicated there is an error which may cause control values and/or patient values to be increased or decreased by as much as 30%.
  • Acción
    Siemens Healthcare is asking customers to discontinue use and dispose the affected stock. A review of previously generated results should be undertaken at the discretion of the Laboratory Director.

Device

Phenobarbitol Reagent (used with ADVIA Chemistry System). An in vitro diagnostic medical device (...
  • Modelo / Serial
    Phenobarbitol Reagent (used with ADVIA Chemistry System). An in vitro diagnostic medical device (IVD)Phenobarbitol Reagent (PHNB_2)Catalogue Number: 10377505Lot Numbers: 244574, 256536ARTG Number: 176643An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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