Retiro De Equipo (Recall) de Sysmex Automated Blood Coagulation Analyzer CS-2100i and 2000i. 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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, has become aware about a software bug with sysmex cs-2100i/2000i analyzers. when the operator registers an order for micro mode and tries to modify the order, there is a risk of a mismatch between the results and sample id numbers. under certain circumstances, measurement results could be assigned to a wrong sample.
  • Acción
    Siemens is providing users with work around instructions to follow. A software update will be implemented to permanently correct the issue.


  • Modelo / Serial
    Sysmex Automated Blood Coagulation Analyzer CS-2100i and 2000i. An in vitro diagnostic medical device (IVD)Catalogue Numbers: SMN 10488583 and 10488585Siemens Reference Number: PH 14-002ARTG Number: 179939
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source