Events

Retiro De Equipo (Recall) de Accu-Chek Inform II Test. 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 Roche Diagnostics Australia Pty Limited.

¿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-2018-RN-00417-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-07
  • 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-2018-RN-00417-1
  • 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
    Roche has identified a certain test strip lot that potentially shows an increase in strip errors prior to dosing. due to the designed fail-safe in the blood glucose meter, the issue can be identified by the error message displayed on the meter upon strip insertion or through the device not recognising the test strip, respectively. however, in a limited number of cases the test strip can produce a biased result i.E. a false high or low value, which might not be detected easily and which could lead to erroneous therapy adaptations.
  • Acción
    Roche is advising customers to identify affected lot numbers from inventory. If impacted stock is identified users should discontinue using strips immediately and discard. Users should use an alternate unaffected lot to monitor patients' glucose levels.

Device

Accu-Chek Inform II Test. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Accu-Chek Inform II Test. An in vitro diagnostic medical device (IVD)Material Number: 05942861022Lot: Number: 476639ARTG Number: 286479(Roche Diagnostics Australia - Clinical chemistry substrate IVDs)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited