Events

Rappel de Thermofisher Remel Bactipstaph Latex Kits

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-01410-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-13
  • 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-01410-1
  • 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
    An internal technical investigation by remel has confirmed that the positive control supplied within these kits may be non-reactive. the latex test reagent provided in the kits performs exactly as expected and according to specifications.No other batches or pack sizes of this product are affected.
  • Action
    Thermofisher is advising users to inspect stock and quarantine any remaining units of the affected batch from use. The requirement for a review of previously generated results is at the discretion of the Laboratory Director.

Device

Thermofisher Remel Bactipstaph Latex Kits
  • Modèle / numéro de série
    Thermofisher Remel Bactipstaph Latex Kits Items Numbers: R21143Lot Numbers: 104809ARTG number 235680 (Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate identification and testing IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand