Retiro De Equipo (Recall) de Dimension Vista Hemoglobin A1c Flex Reagent Cartridge. 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 confirmed that the dimension hb1c flex reagent cartridge lots listed1 exhibit a positive bias averaging 0.4% [4.4 mmol/mol] haemoglobin a1c units and occasionally up to 1.0% [11 mmol/mol] hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp).
  • Acción
    Siemens is advising their customers to discontinue use and discard the affected lots. Retesting HbA1c should be considered in cases where all of the following events have occurred: - HbA1c testing was performed on your patient(s) using the affected lot numbers - There may have been adjustments in therapy based solely on the HbA1c value(s), - There have been no follow up HbA1c testing on the patient since the discontinuation of use of the affected lot numbers. This action has been closed-out on 10/08/2016.


  • Modelo / Serial
    Dimension Vista Hemoglobin A1c Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)Catalogue Number: DF105ASiemens Material Number: 10483822Lot Numbers: GA4266, BA4273, BA4280, BA4287, GA4301, GA4315, GC4322, GA4343, GA4350, GA4357, GA5013 & GA5020ARTG Number: 181689
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source