Events

Rappel de Oxoid Antimicrobial Susceptibility Testing Discs TIM85(Timentin), CT0449B

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-2015-RN-00094-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-10
  • 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-2015-RN-00094-1
  • 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
    Cartridges within the affected batch may contain some discs with a degraded or insufficient level of ingredient (clavulanic acid). a technical investigation confirmed that discs within this lot may have insufficient concentration of ticarcillin/clavulanic acid potentially resulting in below specification zones of inhibition. continued use of this lot could result in a false indication of resistance to timentin.
  • Action
    Customers are advised to inspect stock on hand and and to remove from further use all affected units. On receipt of the Reply Form ThermoFisher will issue a credit note. This action has been closed-out on 24/05/2016.

Device

Oxoid Antimicrobial Susceptibility Testing Discs TIM85(Timentin), CT0449B

Manufacturer

Thermo Fisher Scientific Australia & New Zealand