Events

Retiro De Equipo (Recall) de Dimension Vista System - Blood Urea Nitrogen (BUN) Flex

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 Inc.

¿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
    20244
  • Fecha de inicio del evento
    2016-06-09
  • 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, 55 Hugo Johnston Drive, Penrose, Auckland
  • Causa
    In february 2016, siemens healthcare diagnostics issued field corrective action letter vc 16-01, informing customers of well-to-well accuracy shifts for specific lots of dimension vista bun causing inaccurate patient and/or quality control results. at that time, preliminary investigation demonstrated loss of enzymatic activity of the gldh reagent wells made from a specific mold/cavity. they have since confirmed complaints on additional vista bun flex cartridge lots, suggesting an additional cause of reduced gldh activity.
  • Acción
    Product to be exchanged

Device

Dimension Vista System - Blood Urea Nitrogen (BUN) Flex

Manufacturer

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