Events

Retiro De Equipo (Recall) de TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitoring System). 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 Nipro 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-2016-RN-00632-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-18
  • 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-2016-RN-00632-1
  • 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
    This recall has been initiated as a limited number of sealed test strip vial boxes from the affected trueresult blood glucose test strip batch may include an open test strip vial. test strips contained within open vials are exposed to the outside environment, which can adversely affect the strips performance. in particular, test strips exposed to the environment may provide falsely low blood glucose results. falsely low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment.Action based on falsely low results may raise blood glucose levels further, resulting in potentiated hyperglycemia which may require medical intervention.
  • Acción
    Nipro is advising users to inspect stock and quarantine any remaining stocks of the affected batch for return. This action has been closed-out on 03/02/2017.

Device

TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitorin...
  • Modelo / Serial
    TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitoring System). An in vitro diagnostic medical device (IVD) Item Number: E4i08-81FDExpiry Date: 25/06/2018Batch Number: KS1741ARTG Number: 180121
  • Manufacturer
    Nipro Australia Pty Ltd

Manufacturer

Nipro Australia Pty Ltd