Events

Rappel de Thermo Scientific Remel Shigella sonnei (Phases 1& 2) Agglutinating Serum. 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-01441-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-27
  • 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-01441-1
  • 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 scientific, has confirmed that shigella sonnei (phases 1& 2) agglutinating serum may fail to agglutinate within the specified minimum reaction time when tested with shigella sonnei phase 2 bacteria. continued use of these lots may result in a failure to correctly identify isolates as shigella sonnei phase 2.The products continue to correctly identify shigella sonnei phase 1 bacteria.
  • Action
    Thermo fisher is advising users to inspect stock and remove any remaining units of the affected batches from use. A review of previously generated patient results is at the discretion of the Laboratory Manager.

Device

Thermo Scientific Remel Shigella sonnei (Phases 1& 2) Agglutinating Serum. An in vitro diagnostic...
  • Modèle / numéro de série
    Thermo Scientific Remel Shigella sonnei (Phases 1& 2) Agglutinating Serum. An in vitro diagnostic medical device (IVD) Product code: R30164201Lot Numbers: 1465529, 2118879, 2173683, 2161363, 2149414, 2135578, 1738564, 1957305, 1947930, 1847285ARTG Number: 236824
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand