Events

Rappel de TM0268 GC Sugar Set. 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-2017-RN-01157-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-06
  • 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-2017-RN-01157-1
  • 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
    Thermo fisher received an internal technical investigation confirming that a specific lot of tm0268 gc sugar set may provide atypical performance when used with some strains of neisseria species. false negative results may be seen with the glucose reaction with some strains. continued use of this lot may result in incorrect results reporting or a delay to results reporting due to additional testing requirements.
  • Action
    1. Inspect and remove from further use all units from the affected batch number, then complete the supplied Facsimile Reply Form and return for a credit note to be issued.

Device

TM0268 GC Sugar Set. An in vitro diagnostic medical device (IVD)

Manufacturer

Thermo Fisher Scientific Australia & New Zealand