Events

Retiro De Equipo (Recall) de ADVIA Centaur BR Assay (50 and 250 tests). 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 Healthcare Pty Ltd.

¿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-2017-RN-00389-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-27
  • 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-2017-RN-00389-1
  • 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 confirmation that the advia centaur br (ca 27.29) assay does not dilute linearly when used with multi-diluent 1 kit. when diluted, some samples over-recover the expected neat value by greater than 120%. dilution of samples with results greater than the analytical measuring range for the advia centaur br (ca 27.29) assay may be important for serial measurements during treatment.
  • Acción
    Siemens is requesting users to discontinue dilution of samples using the ADVIA Centaur systems BR (CA 27.29) with Multi-Diluent 1 kit lots ending in 2577 and future lots of Multi-Diluent 1 until further notice. Users are advised to contact their local Siemens Customer Care Centre or their local Siemens technical support representative if they receive any complaints of illness or adverse events associated with the affected products.

Device

ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ADVIA Centaur BR Assay (50 and 250 tests). An in vitro diagnostic medical device (IVD) Catalogue Numbers: 02419937 (116734) and 03896216 (116735) respectivelySiemens Material Numbers (SMN): 10333349 and 10334837 respectivelyLots ending in 2577 and all future lotsSystems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CPARTG Number: 175636
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA