Events

Retiro De Equipo (Recall) de IMMULITE 2000 and IMMULITE 2000 XPi

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-01238-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-21
  • 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-01238-1
  • 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
    In december 2013, siemens healthcare diagnostics issued urgent recall for product correction (tga ref. rc-2014-rn-00002-1) for immulite 2000/immulite 2000 xpi androstenedione due to an observed over-recovery. during efforts to restore performance of the androstenedione assay it was confirmed that the issue noted in december 2013 was not limited to samples >5.5 ng/ml (>19.2 nmol/l). please refer to figures 1 and 2 for more information. the root cause of the over-recovery is related to the variability of a critical raw material.
  • Acción
    Siemens is requesting their customers to discard the affected lot of IMMULITE 2000/IMMULITE 2000 XPi Androstenedione. A laboratory look back is recommended for any existing androstenedione sample(s) with values generated using the affected reagent lots during the period of time within sample stability labelling, and retesting using an alternate method. This action has been closed-out on 16/05/2017.

Device

IMMULITE 2000 and IMMULITE 2000 XPi
  • Modelo / Serial
    IMMULITE 2000 and IMMULITE 2000 XPi Catalogue number: SMN 10381188 Lot number: 314-323ARTG number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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