Events

Retiro De Equipo (Recall) de Genscreen HIV Ag/Ab Ultra. 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 Bio-Rad Laboratories 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-2012-RN-00954-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-09-19
  • 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-2012-RN-00954-1
  • 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
    As a tga condition for product registration, the genscreen hiv ag/ab ultra was accepted for 9 months shelf life not 12 months as stated on the packaging. the genscreen hiv ag/ab ultra kit was distributed to customers after may 2011 without the warning label: "customers are advised to subtract 3 months from the expiry date to obtain the new expiry date of the kit".
  • Acción
    Customers are being advised that for lots within the TGA accepted shelf life investigation of result validity should be carried out as per the package insert and for lots used outside of the accepted shelf life retesting of patient samples should be considered at the discretion of the laboratories Clinical Laboratory Director.

Device

Genscreen HIV Ag/Ab Ultra. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Genscreen HIV Ag/Ab Ultra. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 72386 and 72388Multiple lot numbersARTG Number: 134410
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd