Events

Retiro De Equipo (Recall) de Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. 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-00002-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-02
  • 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-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 has confirmed over-recovery of samples with concentrations greater than 5.5ng/ml (19.2nmol/l) with the immulite/immulite 1000 and immulite 2000/ immulite 2000 xpi androstenedione assays. siemens has determined that these lots are linear up to a concentration of 5.5ng/ml (19.2nmol/l), instead of 10ng/ml (34.9nmol/l) as stated in the instructions for use (ifu). quality control materials at concentrations between 5.5ng/ml (19.2nmol/l) and 10ng/ml (34.9nmol/l) will detect this issue.
  • Acción
    Siemens is advising their customers to use Quality Control materials with at least two levels having concentrations greater that 5.5ng/mL (19.2 nmols/L). Patient values of greater than 5.5ng/mL (19.2 nmols/L) should be verified using an alternate method.

Device

Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. ...
  • Modelo / Serial
    Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. An in vitro diagnostic medical device (IVD)Immulite/Immulite 1000Catalogue Number: LKA01Siemens Material Number: 10381158Lot Number: 409 and aboveImmulite 2000/Immulite 2000XPiCatalogue Number: L2KA02Siemens Material Number: 10381188Lot Number: 314 and aboveARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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