Events

Retiro De Equipo (Recall) de HemoCue Glucose 201 Microcuvettes single packed

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por HemoCue Australia 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-2014-RN-01197-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-11-10
  • 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-01197-1
  • 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
    Hemocue has become aware that the hemocue glucose 201 microcuvette (lot number110718) may, at the end of their shelf-life, yield measurements higher than expected. the higher glucose values may have led to unnecessary insulin treatment or lack of glucose treatment.
  • Acción
    The microcuvettes of this specific lot number have now passed their expiry date and should have been used, or be discarded. It is recommended that the need for repeat testing be determined by the laboratory or clinical director. This action has been clsoed-out on 22/08/2016.

Device

HemoCue Glucose 201 Microcuvettes single packed

Manufacturer

HemoCue Australia Pty Ltd
  • Source
    DHTGA