Events

Rappel de Prosigna Breast Cancer Prognostic Gene Signature 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 Bio-Strategy 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-00563-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-05-08
  • 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-00563-1
  • 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
    The manufacturer nanostrong technologies has identified a quality issue with a single lot of the prosigna kit that may result in an error 35 of the prosigna assay due to high background. a specific failure mode has been observed at an elevated rate with prosigna kit lot 0100531017. this failure mode is pre-emptively identified by the embedded software, resulting in the output of an error by the system without the output of any test result. if this failure mode is experienced, a result for the sample would not have been obtained. if a test result was generated using this lot of kits, those results are not affected.
  • Action
    Bio-Strategy is advising users to quarantine and place all unused kits from lot 0100531017 in a box at ambient temperature ready for collection. Bio-Strategy will arrange for the collection and replacement of unused kits.

Device

Prosigna Breast Cancer Prognostic Gene Signature Assay. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Prosigna Breast Cancer Prognostic Gene Signature Assay. An in vitro diagnostic medical device (IVD)Product Codes: NANPROSIGNA-002, NANPROSIGNA-003Lot Number: 0100531017ARTG Number: 226487
  • Manufacturer
    Bio-Strategy Pty Ltd

Manufacturer

Bio-Strategy Pty Ltd