Events

Rappel de AHG Control Cells 3%. 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 bioCSL 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-2015-RN-01145-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-24
  • 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-2015-RN-01145-1
  • 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 an issue with the ahg control cells not testing as expected. it is giving very weak positive reactions when it should be giving a strong reaction when validating antiglobulin tests.Ih production has determined that the product was not formulated correctly, as the trial pool of the anti-rh sensitising reagent and the bulk were not made to the same strength due to operator error. this has resulted in the bulk anti-rh sensitising reagent being made 10 x weaker than the trial pool. this weak batch was used for formulating the ahg control cells.
  • Action
    The sponsor Seqirus is advising customers to inspect stock and quarantine all affected units prior to their return to the sponsor. The sponsor will arrange the replacement of the affected products or credit the account. This action has been clsoed-out on 29/08/2016.

Device

AHG Control Cells 3%. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    AHG Control Cells 3%. An in vitro diagnostic medical device (IVD)Item Number: 01901371Lot Number: 019075101Expiry Date: 18/12/2015ARTG Number: 224614
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd