Events

Retiro De Equipo (Recall) de Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay 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 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-00874-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-08
  • 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-00874-1
  • 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 for low recovery of magnesium (mg) quality control (qc) and patient samples following calibration of mg with the dimension vista chem 1 cal lot 3gm081. investigation by siemens confirms that qc and patient samples show low recovery of mg by 0.25 mg/dl [0.10 mmol/l] across the assay range following calibration with 3gm081.
  • Acción
    CHEM 1 CAL lot 3GM081 expired on 1 July 2014; however, Siemens is advising their customers to immediately calibrate MG with an alternate lot of CHEM 1 CAL if a calibration of MG with this lot of CHEM 1 CAL is still active. Siemens recommends that the content of this letter and review of previous testing should be discussed with your Medical Director. This action has been closed-out on 03/06/2016.

Device

Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay calibrator). An in vitro ...
  • Modelo / Serial
    Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay calibrator). An in vitro diagnostic medical device (IVD).Catalogue Number: KC110Siemens Material Number: 10445169Lot Number: 3GM081ARTG number: 182222
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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