Events

Retiro De Equipo (Recall) de Dimension Vista Chemistry 3 Calibrator. 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-00236-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-03
  • 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-00236-1
  • 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 “calibrator insert missing” alerts on the affected dimension vista chemistry 3 calibrator. internal investigation has confirmed that the vial barcode label reads kc130 instead of the correct catalogue number kc130a. when this mismatch occurs between the vial barcode label and the instructions for use (ifu) label, the “calibrator insert missing” error is triggered and displayed on the dimension vista instrument screen. there is no risk of erroneous results when this issue occurs as no results are generated.
  • Acción
    Siemens is advising users to use the re-printing options in the Vista system to re-print the affected barcodes. A review of previously generated results is at the discretion of the laboratory director.

Device

Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)Catalogue number: KC130ASiemens Material Number: 10711579Lot Number: 5MD004ARTG number: 182222
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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