Retiro De Equipo (Recall) de HemoCue Urine Albumin Microcuvettes (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 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-2013-RN-00753-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-24
  • 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 a production related problem that affects some single pack pouches of certain lots of urine albumin microcuvettes, where the foil within the pouch has been damaged. if a single pack pouch is damaged, the microcuvettes can be exposed to moisture which in some cases may lead to high false readings.
  • Acción
    HemoCue is asking users to discontinue use of the affected lots. Affected product will be replaced by HemoCue.

Device

  • Modelo / Serial
    HemoCue Urine Albumin Microcuvettes (an in vitro diagnostic medical device (IVD))Lot Numbers: 1208848 to 1304847ARTG Number: 137082
  • Manufacturer

Manufacturer