Events

Rappel de D-10 Rack Loader. 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-2016-RN-00099-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-03
  • 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-00099-1
  • 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
    There is a potential for a sample and result to be mismatched when running in the d-10 rack loader configuration. this means that a patient result may be assigned to an incorrect sample id. while only two instances have been reported, bio-rad wants users to be aware of the possibility.
  • Action
    Bio-Rad is investigating the reported issue and preparing a permanent solution. In the interim, users are advised to not skip positions within the rack. While reviewing results, check the Daily Summary for the following: A. Confirm that the number of results equals the total number of samples run. B. Confirm that injection numbers (I#) within an individual rack (R#) are consecutive. C. Confirm that any sample that was assigned an auto-generated Sample ID is actually missing a barcode label on the sample tube. Bio-Rad Laboratories will release a follow-up communication providing a permanent solution upon completion of a thorough investigation.

Device

D-10 Rack Loader. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    D-10 Rack Loader. An in vitro diagnostic medical device (IVD).Catalogue Number: 220-0600ARTG Number: 212703
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd