Events

Rappel de ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. (An in vitro diagnostic medical device)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Biomerieux Australia 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-2018-RN-00143-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-02-20
  • 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-2018-RN-00143-1
  • 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
    It has been identified that a proportion of kits in the argene range have been mislabelled, where the target name is missing from the tube label. the kits are colour coded by reference to minimise the risk of mixing tubes from different references.
  • Action
    BioMerieux is advising users that the affected product can continue to be used. Users are reminded that the affected products are colour coded by reference, and include the reference number on the labelling.

Device

ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. (An in vitro diagnostic medical d...
  • Modèle / numéro de série
    ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. (An in vitro diagnostic medical device)Adenovirus R-gene Quantification Standard (QS) and Sensitivity Control (SC)Refernece Number: 69-010BLot Number: 1005056960Expiry date: 25/08/2018Parechovirus R-gene Postive control (PC20)Reference Number: 71-020Lot Number: 1005090480Expiry Date: 31/08/2018ARTG Number: 211361 (Biomerieux Australia - Viral infectious disease IVDs)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd