Events

Rappel de BacT/ALERT 3D B.40.xx Firmware (Automated blood culture incubator/growth detector). An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Biomerieux Australia Pty Ltd.

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
    RC-2012-RN-01071-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-10-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01071-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    An improper load occurs when the user performs another action (such as loading a bottle or scanning another bottle) before the reply beeps have been issued. an improper load results in the first bottle not being recognised as being loaded in the instrument and the second bottle's readings being incorrectly reported in association with the first bottle.
  • Action
    Affected laboratories are to implement the corrected User Manual provided by the Sponsor.

Device

BacT/ALERT 3D B.40.xx Firmware (Automated blood culture incubator/growth detector). An in vitro d...
  • Modèle / numéro de série
    BacT/ALERT 3D B.40.xx Firmware (Automated blood culture incubator/growth detector). An in vitro diagnostic medical device (IVD)Product code: 411814 or 411818
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd