Retiro De Equipo (Recall) de Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 confirmed under recovery up to 50% in patient values across the assays reportable range with the affected immulite 2000/immulite 2000 xpi osteocalcin (l2kon2) kit lots. quality control materials will not detect the bias.Osteocalcin can serve as a measure of increased bone resorption in some patient. depending upon the treatment approach, the measurement of osteocalcin may correlate to therapy. in some patients risk of osteoporosis correlates of increasing values of osteoclacin.
  • Acción
    Siemens Healthcare is advising users to discontinue and discard affected lots. Siemens does not currently have a replacement for this product. Siemens is recommending discussing this notice with the medical director regarding the need to review previous test results, conduct patient follow and / or repeat testing for patients tested with the affected lots.


  • Modelo / Serial
    Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysers. An in vitro diagnostic medical device (IVD)Test Code: OCNCatalogue Number: L2KON2Lot Numbers: 218, 219, 220 & 221Siemens Material Number: 10381477ARTG Number: 179720
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source