Events

Rappel de Biomerieux BacT/ALERT System

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 BioMerieux 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
    13674
  • Date de mise en oeuvre de l'événement
    2012-10-24
  • 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: BioMerieux New Zealand Ltd, Suite 4, The Business Connection Office, 2 Kalmia Street, Auckland 1544
  • Cause
    Bact/alert instrument software architecture is linearly designed to scan, proces and load one bottle at a time., manufacturer recently launched the new bact/alert 3d b.40.Xx firmware that contains additional features such as bottle recalculation and bottle authentication. as a result of the additional features customers with control modules containing lbc-586 cpus, distributed from 1997 through november 2007, and running b.40 firmware may exhibit a slightly slower instrument interface issue that may result in bottles being improperly loaded into the instrument.
  • Action
    Instructions for use to be updated

Device

Biomerieux BacT/ALERT System
  • Modèle / numéro de série
    Model: 411814 or 411818, Affected: Firmware version B.40.xx
  • Manufacturer
    BioMerieux Inc

Manufacturer

BioMerieux Inc