Events

Retiro De Equipo (Recall) de Sysmex CS-2100i/2000i Systems (Coagulation Analysers), Software Versions: up to and incl. SW 00-60 (CS-2x00i). 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 Siemens Ltd Diagnostics Division.

¿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-00700-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-19
  • 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-00700-3
  • 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 manufacturer of the device, sysmex corporation, has informed siemens healthcare diagnostics that in a rare occurrence, data attached with a flag indicating “low reliability” was auto-validated and transferred to the host, when settings of the instrument were such that “low reliability” or flagged data should not be validated. in these cases, the data displayed by the host computer does not include the “low reliability” flag.
  • Acción
    Siemens is providing work around instructions for users to implement.

Device

Sysmex CS-2100i/2000i Systems (Coagulation Analysers), Software Versions: up to and incl. SW 00-6...
  • Modelo / Serial
    Sysmex CS-2100i/2000i Systems (Coagulation Analysers), Software Versions: up to and incl. SW 00-60 (CS-2x00i). An in vitro diagnostic medical device (IVD)Model Numbers: 06317410 (CS-2000i), 06372511 (CS-2100i)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA