Events

Rappel de Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (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-2014-RN-00135-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-06
  • 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-2014-RN-00135-1
  • 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 have confirmed that dr0802 oxoid legionella penumophila 2-14 reagent, lot 1265366 may return false negative tests. continued use of this lot may result in a delay to the correct serogroup characterisation of legionella isolates.
  • Action
    Thermo Fisher Scientific is advising users to inspect stock and remove all affected lots from use. Thermo Fisher is advising that the requirement for review of patient results should be determined by the Laboratory Director.

Device

Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (an in v...
  • Modèle / numéro de série
    Oxoid Legionella Latex Test and Oxoid Legionella Penumophila Serogroup 2-14 Test Reagent (an in vitro diagnostic medical device (IVD))Oxoid Legionella Latex Test (DR0800M)Lot Numbers: 1314413 and 1301907Oxoid Legionella Pneumophila Serogroup 2-14 Test Reagent (DR0802M)Lot Number: 1265362
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand