Events

Rappel de The Binding Site Group Human IgM kit for use on SPA Plus

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
    15787
  • Date de mise en oeuvre de l'événement
    2013-12-03
  • 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
    Manufacturer investigations identified that the affected product may be subject to antigen excess effect; even though it's true value was below the claimed level of 56.4g/l. the antigen excess capacity of this product has been reviewed and has been confirmed as correct. investigations have suggested that the tested sample contained predominantly monoclonal igm and the manufacturer believes that this particular type of igm reacted aberrantly with the antibody and subsequently yielded the spurious result.
  • Action
    Instructions for use to be updated

Device

The Binding Site Group Human IgM kit for use on SPA Plus

Manufacturer

The Binding Site Group Ltd