Events

Rappel de Xpert MRSA/SA Blood Culture 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-2016-RN-01487-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-21
  • 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-2016-RN-01487-1
  • 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
    Cepheid has received reports that some customers have experienced a higher number of invalid results than would typically be expected when using this test and its intended use specimen types. as in all xpert assays, when the test is determined to be invalid due to a failure of a cartridge or instrument quality check, no patient results are reported and the report designation is “invalid.”.
  • Action
    Cepheid is advising customers to stop using the affected lot and dispose of any remaining product of this lot in their inventory. Cepheid will provide replacement product. This action has been closed-out on 18/05/2017.

Device

Xpert MRSA/SA Blood Culture Assay. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Xpert MRSA/SA Blood Culture Assay. An in vitro diagnostic medical device (IVD).Catalogue Number: GXMRSA/SA-BC-CE-10Lot Number: 1000025828 (cartridge lot 12803)Expiry date: 2 April 2017ARTG Number: 242177
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd