Events

Rappel de BBL Crystal Enteric/Non-fermenter ID Kit, 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 Becton Dickinson 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-00004-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-01-08
  • 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-00004-1
  • 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
    Becton dickinson has determined that these products have the citrate (cit) and malonic acid (mlo) reagents in the reversed prong/well positions. this may lead to no-identification or multiple identification choices. customers specifically reported split identification results between citrobacter and salmonella, however other bacterial identifications requiring the use of these two substrates may be affected.
  • Action
    Becton Dickinson Pty Ltd is advising customers to discontinue use and discard any affected product. Replacement product or credit will be provided for any discarded product.

Device

BBL Crystal Enteric/Non-fermenter ID Kit, An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    BBL Crystal Enteric/Non-fermenter ID Kit, An in vitro diagnostic medical device (IVD)Catalogue number: 245000Lot number: 2129487Expiration date: 13 March 2013
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd