Events

Rappel de Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum (reagent intended for the identification of Shigella dysenteriae). 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 Oxoid Australia Pty Ltd.

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-00868-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-06
  • 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-00868-1
  • 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 the manufacturer has identified that the listed lot numbers of shigella dysenteriae polyvalent (1-10) agglutinating serum may react with negative isolates, resulting in false positive results.
  • Action
    Oxoid Australia Pty Ltd is recalling the affected batches of product. End users are requested to inspect their stocks and remove from further use all units from the above lot numbers. The requirement for review of patient results should be determined by the laboratory director. This action has been closed-out on 03/06/2016.

Device

Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum (reagent intended for the identifica...
  • Modèle / numéro de série
    Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum (reagent intended for the identification of Shigella dysenteriae). An in vitro diagnostic medical device (IVD)Product Code: R30163701Carton Lot Number: 1111470Bottle Lot Number: 1130078Carton Lot Number: 1236726Bottle Lot Number: 1297592
  • Manufacturer
    Oxoid Australia Pty Ltd

Manufacturer

Oxoid Australia Pty Ltd