Events

Retiro De Equipo (Recall) de cobas 8000 modular analyser series, control unit software version 03-03 (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 Roche Diagnostics Australia Pty Limited.

¿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-00293-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-04
  • 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-00293-1
  • 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
    When using the automatic dilution function on cobas e 602, a software bug occurs leading to an incorrect diluent being used during operation on certain elecsys assays. this happens when all three of the following conditions are present concurrently:- a total of > 2000 reagents kits or diluents had been registered on the cobas e 602 modules within one configuration; and- two or more different diluent types are available on board on the instrument (eg. diluent universal and diluent multiassay); and- a previous diluent (eg diluent universal) had been registered in the database with the identical key information has the current diluent of a different type (eg diluent multiassay).
  • Acción
    Roche is providing work around instructions and a software correction is being developed.

Device

cobas 8000 modular analyser series, control unit software version 03-03 (An in vitro diagnostic m...
  • Modelo / Serial
    cobas 8000 modular analyser series, control unit software version 03-03 (An in vitro diagnostic medical device (IVD)) Affected Elecsys assays and their catalogue numbers:CA 15-3 II (03045838122)CMV IgM (04784618190)Anti-HAV IgM (11820591122)Anti-HBc IgM (11820567122)Rubella IgM (04618831190)Toxo IgM (04618858190)CMV IgG Avidity (05909708190)Cortisol (11875116122)Estradiol II (03000079190)N-MID Osteocalcin (12149133122)Toxo IgG (04618815190)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited