Events

Rappel de Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). 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-2016-RN-00393-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-05
  • 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-2016-RN-00393-1
  • 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
    Internal investigations by oxoid limited have identified variability in concentration of certain lots of timetin tim85. active compound degradation over the shelf life may result in lower than specified concentration leading to out of specification performance results (small zone size).Continued use of this product could result in delayed or false resistance reporting.
  • Action
    Thermo Fisher Scientific is advising users to inspect stock and remove any remaining stocks of the affected product from use. Please complete the reply form and return in order for a credit note to be issued.

Device

Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). A...
  • Modèle / numéro de série
    Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). An in vitro diagnostic medical device (IVD).Product Code: CT0449BAll lots affectedARTG Number: 208273
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand