Events

Retiro De Equipo (Recall) de Simtomax In vitro screening test for Coeliac Disease

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Augurix SA.

¿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
    19941
  • Fecha de inicio del evento
    2016-03-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Smith Biomed (NZ) Ltd, P O Box 8108, Level 2, 44B Victoria Road, New Plymouth
  • Causa
    Due to an issue with over labelling of the simtomax coeliac disease test the expiry dates may not correctly match the stock supplied. the efficacy of the test is not in question however stock received may not necessarily reflect the correct batch that should have been received. the tests are not past their expiry date and the tests that consumers have taken to date had not expired and the efficacy of the test is not in question.
  • Acción
    Product to be returned to supplier

Device

Simtomax In vitro screening test for Coeliac Disease
  • Modelo / Serial
    Model: , Affected: Batches: 192065, 195218, 195220 and 195378
  • Manufacturer
    Augurix SA

Manufacturer

Augurix SA
  • Empresa matriz del fabricante (2017)
    Augurix SA
  • Source
    NZMMDSA