Events

Rappel de Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2mL. 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-2018-RN-00201-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-20
  • 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-2018-RN-00201-1
  • 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 europe, part of thermo fisher scientific, has confirmed that remel neisseria meningitidis poly a-d (r30166601) and neisseria meningitidis group d (r30167001) may fail to agglutinate within the specified minimum reaction time when tested with group d neisseria meningitidis bacteria. continued use of these lots may result in a failure to correctly identify isolates as group d neisseria meningitidis bacteria. the product thermo scientific remel neisseria meningitidis poly a-d (r30166601) continues to correctly identify neisseria meningitidis groups a, b and c. no other batches or pack sizes of this product are affected by this recall.
  • Action
    ThermoFisher is advising users to inspect stock and remove all units of the affected batches from further use. Users should complete the Facsimile Reply Form provided with the Customer Letter to arrange for a credit note to be issued.

Device

Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2m...
  • Modèle / numéro de série
    Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2mL. An in vitro diagnostic medical device (IVD)Catalogue Numbers: R30166601, R30167001Lot Numbers: 2239498, 2177820, 2239861, 1773410 & 1739963. ARTG Number: 236824(Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate agglutination reagent IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand