Events

Rappel de D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). 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-Rad Laboratories 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-2013-RN-01258-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-06
  • 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-2013-RN-01258-1
  • 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 cartridge injection counts not being updated correctly when switching between the d-10 dual short program and extended program on the d-10 haemoglobin testing system due to the incorrect configuration setting in the update kit disk.
  • Action
    As an interim measure, users are advised to manually track the number of injections on the cartridge and monitor the QC results throughout the life of the reorder pack. Bio-Rad is replacing the affected disks with a new update disk to be used with affected Reorder Packs.

Device

D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). An in vitro diagnosti...
  • Modèle / numéro de série
    D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). An in vitro diagnostic medical device (IVD).Catalogue Number: 220-0201Reorder Pack Lot Numbers: 2003022, 20030337, 64000331, 64000332, 64000888, 64001344, 64002239, 64002240 and 64002241Floppy Diskette Lot Numbers: AA30324, AA30339, AA30545, AA31021 AA31023, AA31056, AA31097, AA31193, AA31194 and AA31195CD-ROM Lot Numbers: BA31021, BA31023, BA31056, BA31097, BA31193, BA31194 and BA31195
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd