Events

Rappel de Panocell 16 and Panocell 20. 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-2016-RN-00118-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-02-01
  • 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-00118-1
  • 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
    Reports have been received concerning unexpected positive reactivity when testing donor n3512 with anti-v. donor n3512 was listed as v– (negative) on the master list supplied with these products. immucor have confirmed that this donor is v+ (positive).
  • Action
    Seqirus is providing a revised master list which correctly identifies Donor N3512 as V+ (positive). Seqirus is asking users to evaluate the impact the amended phenotype information may have on results generated with these product lots as per the users' procedures. This action has been closed-out on 04/05/2017.

Device

Panocell 16 and Panocell 20. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Panocell 16 and Panocell 20. An in vitro diagnostic medical device (IVD).Panocell 16Seqirus Product Item: 2332Pack Size: 1 kit (16 cell panel)Lot Number: 39330Expiry Date: 04/12/2015Panocell 20Seqirus Product Item: 5020Pack Size: 1 kit (20 cell panel)Lot Number: 47436 (expiry 29/01/2016), 23160 (expiry 14/08/2015), 14052 (expiry 12/06/15)ARTG Number: 245555
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd