Events

Rappel de Red Blood Cell Antibody Identification Reagent - Phenocell C 0.8% and Phenocell C 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-2013-RN-00638-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2013-06-28
  • 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-2013-RN-00638-1
  • 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 antigen composition sheet supplied with the product listed cell 5 as lu-a negative. however, a customer complaint was received from the imvs adelaide red cell reference laboratory that they typed cell 5 as lua positive. confirmatory testing performed by biocsl in response to the customer complaint has confirmed that cell 5 does type as lu-a positive (weak reaction – score 5 (0-12 scale)).
  • Action
    bioCSL is providing end users with an updated Antigen Composition Sheets for affected kits. The updated information is also provided online at www.biocsl.com.au/IH

Device

Red Blood Cell Antibody Identification Reagent - Phenocell C 0.8% and Phenocell C 3%. An in vitro...
  • Modèle / numéro de série
    Red Blood Cell Antibody Identification Reagent - Phenocell C 0.8% and Phenocell C 3%. An in vitro diagnostic medical device (IVD).Phenocell C 0.8%Catalogue number: 96530201Lot number: 9653 052Phenocell C 3%Catalogue number: 86640201Lot number: 8664 052
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd