Events

Retiro De Equipo (Recall) de Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro 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-01048-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2012-11-01
  • 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-01048-1
  • 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 has received customer inquiries regarding correlation slope bias when comparing the dimension vista alp method to the dimension® alp method. siemens' internal investigation has confirmed that the activity of the dimension vistaalp cal, kc330, changes as the product ages and contributes to this correlation slope bias as well as accuracy shift. the magnitude of the accuracy shift is the same for qc and patient samples and does not exceed the allowable bias for the dimension vista alp assay. in order to ensure better correlation and accuracy, the shelf life for the dimension vista alp cal has been decreased from 12 months to 4 months.
  • Acción
    Siemens is providing work around instructions for users to implement.

Device

Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro diagnostic medical device...
  • Modelo / Serial
    Dimension Vista ALP Calibrator (clinical chemistry enzyme). An in vtiro diagnostic medical device (IVD)Catalogue Number: KC330Siemens Material Number: SMN 10445181Lot number recalled : 2AD052Lot numbers whose shelf life will be reduced: 2GD011 and higherARTG Number: 181688
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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