Events

Rappel de Genscreen HIV Ag/Ab Ultra. 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-2012-RN-00954-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-09-19
  • 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-2012-RN-00954-1
  • 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
    As a tga condition for product registration, the genscreen hiv ag/ab ultra was accepted for 9 months shelf life not 12 months as stated on the packaging. the genscreen hiv ag/ab ultra kit was distributed to customers after may 2011 without the warning label: "customers are advised to subtract 3 months from the expiry date to obtain the new expiry date of the kit".
  • Action
    Customers are being advised that for lots within the TGA accepted shelf life investigation of result validity should be carried out as per the package insert and for lots used outside of the accepted shelf life retesting of patient samples should be considered at the discretion of the laboratories Clinical Laboratory Director.

Device

Genscreen HIV Ag/Ab Ultra. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Genscreen HIV Ag/Ab Ultra. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 72386 and 72388Multiple lot numbersARTG Number: 134410
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd