Events

Rappel de Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. 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 Seqirus 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-00658-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-05
  • 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-00658-1
  • 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
    Seqirus has identified that donor #4138503 was listed as d - (negative) on the antigen composition sheet(s) provided with the affected products. subsequent testing of this donor has indicated weak d reactivity. donor #4138503 may be agglutinated by some examples of anti d and the weak d antigen expression of this donor is only detectable by some test methods. this donor has been identified as a possible weak d variant.
  • Action
    Seqirus has provided users with an interim workaround in the Customer Letter.

Device

Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. An in vitro diagnostic medical device (IVD)Phenocell B 0.8%Item Number: 26530201Lot Number: 2653164Cell Number: Cell #6Phenocell B 3%Item Number: 16640201Lot Number: 1664164Cell Number: Cell #6Abtectcell III 0.8% RhD Negative Screening CellsItem Number: 22230201Lot Number: 2223123Cell Number: Cell #1Expiry Date: 12/06/2017ARTG Number: 223867
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd