Events

Retiro De Equipo (Recall) de D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). 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-2013-RN-01258-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-06
  • 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-2013-RN-01258-1
  • 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
    The cartridge injection counts not being updated correctly when switching between the d-10 dual short program and extended program on the d-10 haemoglobin testing system due to the incorrect configuration setting in the update kit disk.
  • Acción
    As an interim measure, users are advised to manually track the number of injections on the cartridge and monitor the QC results throughout the life of the reorder pack. Bio-Rad is replacing the affected disks with a new update disk to be used with affected Reorder Packs.

Device

D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). An in vitro diagnosti...
  • Modelo / Serial
    D-10 Dual Program Reorder Pack (used with D-10 Haemoglobin Testing System). An in vitro diagnostic medical device (IVD).Catalogue Number: 220-0201Reorder Pack Lot Numbers: 2003022, 20030337, 64000331, 64000332, 64000888, 64001344, 64002239, 64002240 and 64002241Floppy Diskette Lot Numbers: AA30324, AA30339, AA30545, AA31021 AA31023, AA31056, AA31097, AA31193, AA31194 and AA31195CD-ROM Lot Numbers: BA31021, BA31023, BA31056, BA31097, BA31193, BA31194 and BA31195
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd