Events

Rappel de BacT/ALERT BPN Culture Bottles. 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-2017-RN-00794-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-23
  • 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-2017-RN-00794-1
  • 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
    Biomérieux has become aware of a crimp defect associated with the bact/alert bpn culture bottles. an anomaly was identified during the manufacturing process that may lead to having excess material at the neck of the bottle. this material may separate from the crimp exposing a sharp edge or causing a minor cut hazard.
  • Action
    Customers are requested to: - Confirm this letter has been distributed to and reviewed by all appropriate personnel within the organisation. - Review inventory of BacT/ALERT BPN bottles for Lot Number 1048256 and discard all affected bottles from this lot. Please store this letter with your bioMerieux instrument documentation.

Device

BacT/ALERT BPN Culture Bottles. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    BacT/ALERT BPN Culture Bottles. An in vitro diagnostic medical device (IVD)Reference Number: 279045Lot Number: 1048256ARTG Number: 194228
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd