Events

Rappel de Remel PathoDx Strep Grouping Kit 60 Test containing Remel PathoDx Strep B Group Latex. 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-2015-RN-00380-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-05
  • 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-2015-RN-00380-1
  • 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 by the manufacturer remel europe, part of thermo fisher scientific, have confirmed that this batch of group b reagent may produce weak or slow reactions. continued use of this batch may result in a failure to identify beta-haemolytic streptococci group b isolates potentially leading to a delay in result reporting and/or a delay to delivering appropriate therapy.
  • Action
    Laboratories are requested to cease using and destroy the kits containing the affected reagent. This action has been closed-out on 08/08/2016.

Device

Remel PathoDx Strep Grouping Kit 60 Test containing Remel PathoDx Strep B Group Latex. An in vitr...
  • Modèle / numéro de série
    Remel PathoDx Strep Grouping Kit 60 Test containing Remel PathoDx Strep B Group Latex. An in vitro diagnostic medical device (IVD)Remel PathoDx Strep Grouping Kit 60 Test (R62025) Lot 1470133 Remel PathoDx Strep B Group Latex Lot 1437729ARTG number: 235676
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand