Events

Retiro De Equipo (Recall) de Sysmex CS-2100i and CS-5100 Automated blood coagulation analysers

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-2014-RN-00331-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-14
  • 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-2014-RN-00331-1
  • 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 manufacturer of the analyser, sysmex corporation, has informed siemens healthcare diagnostics about an issue potentially affecting the factor viii results. the factor viii chromogenic assay generates a curve from which a percentage result is calculated. the sysmex cs-2100i and cs-5100 automated blood coagulation analysers may generate an irregular curve that under certain circumstances could lead to an erroneously increased result with a factor viii chromogenic assay. the irregular curve is not flagged by the system.
  • Acción
    Siemens is advising their customers to run all Factor VIII Chromogenic assays in duplicate and confirm results in conjunction with the patient's clinical history. A software update is expected to be completed mid-2014 to correct the issue.

Device

Sysmex CS-2100i and CS-5100 Automated blood coagulation analysers
  • Modelo / Serial
    Sysmex CS-2100i and CS-5100 Automated blood coagulation analysersCatalogue Numbers: 10488062 and 10708128ARTG Number: 179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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