Events

Rappel de MIA FORA NGS HLA FLEX 11 KIT (24 tests). 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-01491-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-06
  • 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-2017-RN-01491-1
  • 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 made aware by the manufacturer, bioarray solution, that a limited number of mia fora ngs hla flex 11 kit (24 tests) ce kits lot 18- 107-11-c contain index adaptor plates (iap) p/n sr-800-00349, lot 18-30a that may result in incorrect calls for samples in the f1 and g1 plate positions due to switched barcode adaptors in positions f1 and g1. the impact of a defective iap when used for testing will result in the wrong call at plate positions f1 and g1 and therefore an incorrect result.
  • Action
    Diagnostic Solutions is advising customers to quarantine all units of Lot 18-107-11-C from inventory. Diagnostic Solutions will confirm with users whether any of their stock is defective and will arrange for replacement of defective units. Diagnostic Solutions recommend that all F1 and G1 sample results generated with the MIA FORA NGS HLA FLEX 11 KIT (24 tests) Lot 18-107-11-C are retested to confirm samples have been correctly identified.

Device

MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD) Lot Number: 18-107-11-CARTG Number: 288368
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd