Retiro De Equipo (Recall) de Nova StatStrip and StatSensor Blood Monitoring Systems. An in vitro diagnostic medical device (IVD)(Point of Care System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Australasian Medical & Scientific 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
  • 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
    This recall action is to alert users that lithium batteries utilized beyond their intended useful life may swell and/or crack the external case posing a potential safety hazard. in some cases, the swelling may cause the battery door on the meter to incorrectly seat rendering the meter inoperable.
  • Acción
    AMSL is advising users that all batteries without an expiration date label will be replaced. AMSL recommends a battery inspection program is implemented to identify and remove batteries from point of use that do not have expiration dates on the battery label.


  • Modelo / Serial
    Nova StatStrip and StatSensor Blood Monitoring Systems. An in vitro diagnostic medical device (IVD)(Point of Care System)ARTG Number: 197482
  • Manufacturer