Events

Retiro De Equipo (Recall) de Dimension Clinical Chemistry System and Dimension Vista 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-2017-RN-00002-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-04
  • 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-2017-RN-00002-1
  • 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 determined that some lots of ammonia (amm) reagent used on both the dimension® and dimension vista® systems do not meet the 60-day calibration interval claim due to reagent instability and results may show an abnormal assay message. these lots may exhibit accuracy shifts for patient and/or quality control results; which may cause laboratories to recalibrate more frequently than the of 60-day claim in the instructions for use (ifu).
  • Acción
    Siemens is advising customers to discard affected lots and to use alternate lots instead. Customers are also to check the acceptability of the calibration and QC.

Device

Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical de...
  • Modelo / Serial
    Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD).Dimension Clinical Chemistry SystemAssay: Ammonia AMMCatalogue No: DF119SMN: 10711991Lots: FB7152 (Exp 1/6/17), EB7180 (Exp 29/6/17), BA7194 (Exp 13/7/17), EA7223 (Exp 11/8/17), BA7250 (Exp 7/9/17)Dimension Vista SystemAssay: Ammonia AMMCatalogue No: K3119SMN: 10711992Lots: 16187BE (Exp 5/7/17), 16225BB (Exp 12/8/17), 16265AB (Exp 21/9/17)ARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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