Events

Rappel de Dimension Vista System - Blood Urea Nitrogen (BUN) Flex

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 Siemens Healthcare Diagnostics Inc.

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
    20244
  • Date de mise en oeuvre de l'événement
    2016-06-09
  • 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: Siemens Healthcare (NZ) Ltd, 55 Hugo Johnston Drive, Penrose, Auckland
  • Cause
    In february 2016, siemens healthcare diagnostics issued field corrective action letter vc 16-01, informing customers of well-to-well accuracy shifts for specific lots of dimension vista bun causing inaccurate patient and/or quality control results. at that time, preliminary investigation demonstrated loss of enzymatic activity of the gldh reagent wells made from a specific mold/cavity. they have since confirmed complaints on additional vista bun flex cartridge lots, suggesting an additional cause of reduced gldh activity.
  • Action
    Product to be exchanged

Device

Dimension Vista System - Blood Urea Nitrogen (BUN) Flex
  • Modèle / numéro de série
    Model: K1021, Affected: 16004AB, 16033AC, 16034AA, 16048AA, 16055AA,16055AB, 16062AA,16062AB
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    NZMMDSA