Events

Retiro De Equipo (Recall) de Dimension Clinical Chemistry System - Haemoglobin A1c (HbA1c). 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-00849-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-21
  • 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-00849-3
  • 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 has received complaints of inaccurate results after calibration of hb1c (df105a). accuracy shifts of up to 27%, both high and low, have been reported on qc and patient samples. the shift observed with qc material is consistent with the direction and magnitude of the shift observed with patient samples.
  • Acción
    End user to use updated scaler values for calibration of all affected lots.

Device

Dimension Clinical Chemistry System - Haemoglobin A1c (HbA1c). An in vitro diagnostic medical dev...
  • Modelo / Serial
    Dimension Clinical Chemistry System - Haemoglobin A1c (HbA1c). An in vitro diagnostic medical device (IVD) Catalogue Number: DF105ALot Numbers: GA3169, GA3162, GA3141, GA3134, GA3113 & GA3099ARTG Number: 181689
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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