Events

Rappel de Phenocell A 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-2014-RN-00986-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-12
  • 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-2014-RN-00986-1
  • 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
    A phenotyping error has been identified on the antigen composition sheet supplied with phenocel a, lot 0664933. the error relates to the colton b (cob) phenotype listed for cell 9. the antigen composition sheet supplied with these products stated cell 9 as cob negative. a complaint received by biocsl reported that cell number 9 was confirmed to be positive (cob+).
  • Action
    bioCSL is providing affected customers with an amended Antigen Composition Sheet for Phenocell A 3% Lot 0664933 which must replace the original Antigen Composition sheet. This amended Antigen Composition Sheet is also available for download via the Customer Service Portal login section on bioCSL's website: www.biocsl.com.au/IH. This action has been closed-out on 02/05/2017.

Device

Phenocell A 3%. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Phenocell A 3%. An in vitro diagnostic medical device (IVD).Item Number: 06640201Lot Number: 0664933Expiry: 29/09/2014ARTG: 223867
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd