Events

Retiro De Equipo (Recall) de ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CPADVIA Centaur Systems TSH3 Ultra 100T, 500T

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-00441-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-17
  • 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-00441-1
  • 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 has confirmed that samples containing fluorescein (dye commonly used in fluroescein angiography) may show interference with the advia centaur systems tsh3 ultra, vitamin d and the advia centaur brahms procalcitonin assays.
  • Acción
    Siemens is notifying their customers of the potential for samples with fluorescein to show interference and the Instructions for Use are currently being updated.

Device

ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CPADVIA Centaur Systems TSH3 Ultra 100T, 500T
  • Modelo / Serial
    ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CPADVIA Centaur Systems TSH3 Ultra 100T, 500TCatalogue No: 06491072 & 06491080Kit Lots Ending In: 266, 267, 269, 270, 271, 272 & 273ADVIA Centaur Systems VitD 100T, 500TCatalogue No: 10491994, 10699201, 10631021 & 10699533Kit Lots Ending In: 023, 024, 025, 026, 027, 050, 051, 052, 053 & 054ADVIA Centaur BRAHMS PCT 100TCatalogue No: 10378883Kit Lots Ending In: 020, 021, 022, 023 & 024ARTG No: 175698 & 175700
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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