Events

Retiro De Equipo (Recall) de LOCI Cardiac Troponin I Calibrator (used with Dimension EXL Clinical Chemistry Systems)

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-2013-RN-00972-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-16
  • 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-2013-RN-00972-1
  • 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
    Internal testing has confirmed customer complaints regarding an upward shift in qc and patient results following calibration with loci cardiac troponin i calibrator lot 3dd007. based on initial internal investigation, siemens estimates that approximately 40% of the calibrator lot is affected. internal testing on patient samples demonstrated an average upward shift of 24% range when compared to an unaffected lot.
  • Acción
    Siemens is requesting their customers to immediately discontinue use and discard any remaining inventory from the affected lot. Siemens is recommending to discuss the issues and requirement for retesting with the medical director. The recommendations regarding the need to review previous QC and patient results is limited to samples tested within the past 24 hours.

Device

LOCI Cardiac Troponin I Calibrator (used with Dimension EXL Clinical Chemistry Systems)
  • Modelo / Serial
    LOCI Cardiac Troponin I Calibrator (used with Dimension EXL Clinical Chemistry Systems)Catalogue Number: RC621Siemens Material Number: 10464336Lot Number: 3DD007ARTG Number: 1822774An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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