Events

Retiro De Equipo (Recall) de Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE)

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-00334-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-18
  • 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-00334-1
  • 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 a complaint for under-recovery of patient samples with the dimension vista csa flex reagent cartridge when whole blood samples are run from small sample container (ssc). investigations by siemens have confirmed that csa, as well as csae, under-recovers by 18% to 44% when whole blood samples are run from ssc.
  • Acción
    Siemens is advising end users to cease using small Sample Containers when running whole blood samples with Dimension Vista CSA and CSAE assays. A review of previously reported results is recommended for cyclosprine samples run in Small Sample Containers. This action has been closed-out on 01/02/2016.

Device

Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE)
  • Modelo / Serial
    Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE) Flex Reagent CartridgeDimension Vista CSA:Catalogue Number: K4089Siemens Material Number: 10445139Lot Numbers: 13114BA, 13157BA, 13246BB, 13317BA, 14008BB & 14050BBDimension Vista CSAE:Catalogue Number: K4108Siemens Material Number: 10445142Lot Numbers: 13157BC & 13429BDARTG Number: 182779
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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