Events

Retiro De Equipo (Recall) de Siemens Immulite Androstenedione

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Siemens Healthcare Diagnostics Products Limited.

¿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
    16460
  • Fecha de inicio del evento
    2014-03-27
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    Siemens healthcare diagnostics has confirmed over-recovery of samples with concentrations greater than 5.5 ng/ml (19.2 nmol/l) with the immulite/immulite 1000 and immulite 2000/immulite 2000 xpi androstenedione assays (lkao1, l2kao2)., siemens has determined that these lots are linear up to a concentration of 5.5 ng/ml (19.2 nmol/l), instead of 10 ng/ml (34.9 nmol/l) as stated in the instructions for use (ifu). quality control materials at concentrations between 5.5 ng/ml (19.2 nmol/l) and 10 ng/ml (34.9 nmol/l) will detect this issue., this is a follow up to the above where siemens is now providing supplementary information regarding the dilution of androstenedione samples >5.5ng/ml (19.2 nmol/l) as an alternative to verifying samples with an alternate method.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens Immulite Androstenedione

Manufacturer

Siemens Healthcare Diagnostics Products Limited
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA