Events

Rappel de Xpert CT/NG Assay. 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 Cepheid Holdings 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-2017-RN-00375-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-21
  • 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-00375-1
  • 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
    Reports have been received that some customers have experienced a higher number of invalid results than would typically be expected when using the xpert ct/ng assay and its intended use specimen types. this could lead to the need to retest and consequently, a delay in test results and subsequent treatment.
  • Action
    Cepheid is advising users to discontinue use and discard affected stock in their inventory. Users are further advised to acknowledge receipt of the recall letter and return it to Cepheid customer service in order to receive replacement stock.

Device

Xpert CT/NG Assay. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Xpert CT/NG Assay. An in vitro diagnostic medical device (IVD)Catalogue Number: GXCT/NG-CE-10Lot Number: 100044234Cartridge Lot Number: 11715Expiration Date: 29 July 2018ARTG Number: 207540
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd