Events

Rappel de Thioglycollate Medium (bacteria culture media). 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 Thermo Fisher Scientific Australia & New Zealand.

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-2014-RN-00728-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-04
  • 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-2014-RN-00728-1
  • 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
    Investigations have confirmed that some vials within some boxes of this batch may fail to support the growth of clostridium sporogenes. continued use of this lot could result in failure to detect this or similar anaerobic bacteria. the medium was found to still support the growth of all aerobic bacteria tested.
  • Action
    Oxoid Australasia is requesting their customers remove any affected stock from further use. Arrangements will be made for replacement or credit note to be provided.

Device

Thioglycollate Medium (bacteria culture media). An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Thioglycollate Medium (bacteria culture media). An in vitro diagnostic medical device (IVD)Product code: TM0935Lot number: 1291980ARTG number: 214128
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand