Events

Rappel de MIA FORA NGS Software v3.27.0. 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 Diagnostic Solutions 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-01303-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-24
  • 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-01303-1
  • 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
    Diagnostic solutions has been advised that as a result of a complaint investigation, it has been determined that mia fora ngs software is impacted by an error in the v3.27.0 reference database update. customers testing all 11 hla genes, 9 hla genes and 6 hla genes with the mia fora ngs flex hla kits are impacted. reference sequences specific to hla-drb6 and other non-target reference sequences were inadvertently omitted from the v3.27.0 reference database and as a result, this may impact the accuracy of the automatic calls and the need to manually review results. this is most frequently observed with hla-dpb1 results.
  • Action
    Diagnostic Solutions will be in contact with users when a software update is available to include the revised reference database. In the interim, users may utilise either of the following options: 1. Continue use of the v3.27.0 reference database and manually inspect all DPB1 results pending availability of the corrected database; or 2. Revert to v3.24.0. Guidance on how to do this may be provided upon request by Immucor. Note: after reverting to v3.24.0 users must reanalyse projects previously analysed with the v3.27.0 reference database using the v3.24.0 reference database.

Device

MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    MIA FORA NGS Software v3.27.0. An in vitro diagnostic medical device (IVD)ARTG Number: 288607
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd