Events

Retiro De Equipo (Recall) de Dimension Chemistry Wash

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-2013-RN-00471-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-17
  • 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-00471-1
  • 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
    Siemens healthcare diagnostics has received complaints of chemistry wash causing qc and patient sample result shifts on ctni, ltni, ft4, tsh, pbnp and lpbn when using chemistry wash lots rd23031, rd23111, rd23241, rd23311, rd23391, and rd23461.
  • Acción
    Siemens is requesting their customers to discontinue use of all affected lots and to ensure that calibration of assays have been calibrated with unaffected lots.

Device

Dimension Chemistry Wash
  • Modelo / Serial
    Dimension Chemistry WashCatalogue number: RD701Siemens material number: 10445052Lot numbers:RD23031 - Expiry 29 Apr 2013RD23111 - Expiry 7 May 2013RD23241 - Expiry 19 May 2013RD23311 - Expiry 26 May 2013RD23391 - Expiry 4 June 2013RD23461 - Expiry 11 June 2013ARTG number: 182554
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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