Events

Rappel de Binding Site Human IgG4 Immage Kit

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 The Binding Site Group Ltd.

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
    17369
  • Date de mise en oeuvre de l'événement
    2014-09-17
  • 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: In Vitro Technologies, 26-30 Vestey Drive, Mount Wellington, Panmure, Auckland
  • Cause
    As a result of customer complaints, the manufacturer (the binding site) has identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results., as the binding site's igg4 assay was developed specifically for igg4 deficiency the assay has limited antigen excess capacity and therefore the analysis of samples from the hyper igg4 disease cohort may introduce the potential for antigen excess.
  • Action
    Instructions for use to be updated

Device

Binding Site Human IgG4 Immage Kit

Manufacturer

The Binding Site Group Ltd