Events

Rappel de BacT/ALERT PF Plus Culture Bottle. 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-2013-RN-00913-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2013-08-30
  • 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-2013-RN-00913-1
  • 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
    Bact/alert pf plus culture bottle, lot 1033298, yielded reflectance results above the stability specification at the 9-month time frame. bottles that have reflectance results near or greater than the initial value threshold specification when first loaded on the instrument could have an increased probability of false positive results.
  • Action
    Bio Merieux is requesting their customers to discontinue use of the affected batch remaining in stock. Bottles that are already inoculated or incubating should be allowed to complete their testing/incubation. All bottles flagged positive by the instrument should continue to be treated as stated in the instructions for use.

Device

BacT/ALERT PF Plus Culture Bottle. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    BacT/ALERT PF Plus Culture Bottle. An in vitro diagnostic medical device (IVD)Catalogue Number: 410853Lot Number: 1033298Expiration Date: 16 October 2013
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd