Events

Rappel de Immuno Anti-dsDNA 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 manufacturer #1479.

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
    17925
  • Date de mise en oeuvre de l'événement
    2015-01-12
  • 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: Immuno Ltd, Level 1, 330 Ti Raukau Drive, East Tamaki, Auckland
  • Cause
    Specific product codes for the anti-dsdna kit (used to test for antibodies to dsdna), were omitted in error from the packaging material. customers have received the correct products, however due to the omission of the product code on the outer box it is not clearly identifiable if they have received the 50 tests version (im77 lot c323026) or 100 tests version (im771 lot c323027). the kits can be differentiated by the lot numbers printed on the outer box. please note that the individual component labelling within the kit has not been affected. the tracer and ammonium sulphate solution lot numbers were omitted for these particular lots of product listed above.
  • Action
    Instructions for use to be updated

Device

Immuno Anti-dsDNA Kit
  • Modèle / numéro de série
    Model: Product codes: IM77 (50 tests), IM 771 (100 tests), Affected: Batch Numbers: C323026 (50 tests), C323027 (100 tests)
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479