Events

Retiro De Equipo (Recall) de Dimension clinical chemistry system and Dimension Vista System

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
    22934
  • Fecha de inicio del evento
    2018-05-07
  • 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
    The manufacturer has confirmed dimension gentamicin (gent) lot bb8159 may exhibit inaccuracy for quality control (qc) and patient samples at the low end of the analytical measurement range. maximum negative bias of 100% and 48% were observed for patient samples at 0.9 mg/l [1.94 µmol/l] and 1.9 mg/l [4.1 µmol/l], respectively. patient samples at 2.6 mg/l [5.62 µmol/l] did not show a bias. the bias is due to the calibration curve not showing separation between the level 1 and level 2 calibrators.
  • Acción
    Product to be destroyed

Device

Dimension clinical chemistry system and Dimension Vista System

Manufacturer

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