Events

Rappel de ALBAclone Advanced Partial RhD Typing Kit. 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 Haemokinesis 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-2017-RN-00628-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-25
  • 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-2017-RN-00628-1
  • 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 manufacturer has found that lot no v174693 has a reduced level of performance associated with components h and l, which are generating weaker than normal reactions with some weak rhd and partial rhd samples. reduced reactivity of components h and l is considered to make interpretation of the rhd variant sample type more difficult given results are available from only ten of the twelve monoclonal anti-d cell lines contained in the kit.
  • Action
    Haemokinesis is advising users to quarantine and dispose of the affected lots. Haemokinesis will provide replacement stock or will issue a credit note. For previously generated results, the laboratory Medical Director should take into consideration the possible reduced reactivity of component H and L.

Device

ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD)Product Code: Z293Lot Number: V174693Expiry Date: 13 July 2017ARTG Number: 225063
  • Manufacturer
    Haemokinesis Pty Ltd

Manufacturer

Haemokinesis Pty Ltd