Events

Rappel de Simtomax In vitro screening test for Coeliac Disease

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Augurix SA.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    19941
  • Date de mise en oeuvre de l'événement
    2016-03-29
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Smith Biomed (NZ) Ltd, P O Box 8108, Level 2, 44B Victoria Road, New Plymouth
  • Cause
    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.
  • Action
    Product to be returned to supplier

Device

Simtomax In vitro screening test for Coeliac Disease
  • Modèle / numéro de série
    Model: , Affected: Batches: 192065, 195218, 195220 and 195378
  • Manufacturer
    Augurix SA

Manufacturer

Augurix SA
  • Société-mère du fabricant (2017)
    Augurix SA
  • Source
    NZMMDSA