Events

Retiro De Equipo (Recall) de Phenocell A 3%. An in vitro diagnostic medical device (IVD).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por bioCSL Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00986-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00986-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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+).
  • Acción
    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).
  • Modelo / Serial
    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