Events

Retiro De Equipo (Recall) de Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). 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 Healthcare Pty Ltd.

¿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-2016-RN-00661-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-19
  • 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-2016-RN-00661-1
  • 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 positive shift of patient and qc results when the alti assay is calibrated with the affected dimension enzyme ii calibrator lots. internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. there is no risk to patients however there may be a delay in results.
  • Acción
    Siemens has reassigned the bottle values of all Enzyme II calibrator lots currently in date. Laboratories may expect to observe a downward shift of approximately 8% in QC, patient samples and proficiency testing materials when reassigned bottle values are used for calibration. Siemens recommends recalibration of existing Alanine Aminotransferase (ALTI) flexes and future calibrations using the reassigned calibrator bottle values for lots provided. A review of previously generated results due to this issue is at the discretion of the laboratory.

Device

Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro diagn...
  • Modelo / Serial
    Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD)Product Code: ENZ II CALCatalogue Number: DC143Siemens Material Number (SMN): 10476170Multiple Lot Numbers and Expiry Dates affectedARTG Number: 181688
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA