Events

Rappel de Various Microgenics Application Sheets

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 Microgenics Corporation.

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
    21578
  • Date de mise en oeuvre de l'événement
    2017-06-28
  • 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: Thermo Fisher Scientific New Zealand Ltd, 244 Bush Road, Albany, AUCKLAND
  • Cause
    During an internal assessment, it was found that certain application sheets provided by thermo fisher new zealand for expanded use of some assays on analyzers that are not listed in the assay instructions for use are inadequate. specifically, the validation data included in the application sheets for the expanded use of these assays, is inadequate and will not be included in future application sheets. in addition, statements have been added to the application sheets that explain that the parameter settings are not supplier qualified and are to be used for instrument programming guidance only, and that each assay used on a non-microgenics approved analyzer needs to be validated individually by the user.
  • Action
    Instructions for use to be updated

Device

Various Microgenics Application Sheets
  • Modèle / numéro de série
    Model: , Affected: Incomplete Instructions for Use for Microgenics Application Sheets
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation