Events

Retiro De Equipo (Recall) de ADVIA Centaur Homocysteine (HCY) Assay used with the ADVIA Centaur, Centaur XP, and Centaur CP systems

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-2013-RN-00672-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-07-03
  • 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-2013-RN-00672-1
  • 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 have identified that the percent recovery for 1:10 diluted patient sample dilutions is lower than reported in the instructions for use (ifu). dilution of patient samples is primarily used to resolve results above the diagnostic range of the hcy assay.
  • Acción
    Siemens is advising end users to ensure that 1:10 sample dilution testing is no longer carried out. The performance of 1:2 sample dilutions has been confirmed to meet the IFU recoveries and can continue to be tested. This action has been closed-out on 07/09/2016.

Device

ADVIA Centaur Homocysteine (HCY) Assay used with the ADVIA Centaur, Centaur XP, and Centaur CP sy...
  • Modelo / Serial
    ADVIA Centaur Homocysteine (HCY) Assay used with the ADVIA Centaur, Centaur XP, and Centaur CP systemsMultiple Catalogue numbers and Lot numbers affectedARTG Number: 175075 An 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