Retiro De Equipo (Recall) de HemoCue Glucose 201 RT and 201 DM RT Systems. A point of care 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 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-2012-RN-00749-3
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-07-26
  • País del evento
  • Fuente del evento
    DHTGA
  • 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
    Hemocue has become aware of indications of in-correct high readings of hemocue glucose 201 rt and hemocue glucose 201 dm rt for the application of monitoring of blood glucose levels on pre-term neonates. on full-term neonates there are no similar indications but as a precaution hemocue has decided to replace all systems on delivery and neonatal wards with hemocue glucose 201+ or hemocue glucose 201 dm while investigations continue.
  • Acción
    HemoCue is recalling affected devices and is replacing them with unaffected models

Device

  • Modelo / Serial
    HemoCue Glucose 201 RT and 201 DM RT Systems. A point of care in vitro diagnostic medical device (IVD). Affected Product Numbers: 124713 and 124013
  • Manufacturer

Manufacturer