Events

Retiro De Equipo (Recall) de Siemens Immulite GI-MA CA19-9

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
    18129
  • Fecha de inicio del evento
    2015-02-20
  • 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 a positive bias with the bio-rad lyphochek® tumor marker plus control and the bio-rad liquichek™ tumor marker control when used with immulite® 2000/immulite® 2000 xpi gi-ma (ca 19-9) assay kit lots 312 and 313., in addition, a greater than expected change in patient sample recovery may be observed when moving from kit lot 311 to kit lots 312 and above., when comparing kit lot 312 with kit lot 311, siemens observed an average percent bias of 38% (ranging from 30% to 47%) for patient samples recovering from 29.6 to 44.4 u/ml and an average percent bias of 5% (ranging from 1% to 11%) for patient samples recovering from 540 to 660 u/ml., future kit lots are expected to recover quality control and patient samples similar to kit lot 312.
  • Acción
    Instructions for use to be updated

Device

Siemens Immulite GI-MA CA19-9

Manufacturer

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