Events

Rappel de Siemens Dimension Vista System - Blood Urea Nitrogen (BUN) Flex Reagent Cartridge Well-to-Well Accuracy Shifts - Resolution

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
    20460
  • Date de mise en oeuvre de l'événement
    2016-08-02
  • 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, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Cause
    Siemens has now implemented additional pre-release testing for all vista bun flex reagent lots. the additional testing ensures acceptable lot performance including gldh activity. beginning with dimension vista bun flex lot 16110ac (expiration date 2017-04-19), and for all subsequent lots that expire after this date, customers will no longer be required to follow the directions in ufsn letters vc-16-01 (issued feb 2016) and vc-16-01a (issued june 2016).
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens Dimension Vista System - Blood Urea Nitrogen (BUN) Flex Reagent Cartridge Well-to-Well Ac...
  • Modèle / numéro de série
    Model: Dimension Vista Blood Urea Nitrogen (BUN) Well-to-Well accuracy shifts, Affected: 15215AE, 15243BB,15264BA,15299BB,15300BA, 15320BB, 15341AC
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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