Events

Retiro De Equipo (Recall) de Siemens Advia Liquid Specific Protein (LSP) Calibrator

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
    17675
  • Fecha de inicio del evento
    2014-11-12
  • 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 two issues with the siemens liquid specific protein (lsp) calibrator lot 303574:, issue 1: siemens has observed an increased frequency of max fit deviation flags using the liquid specific protein (lsp) calibrator kit lot 303574 (vial lots 122it - 127it) to calibrate the alpha-1-antitrypsin (aat) assay., issue 2: siemens has confirmed that a preliminary version of the liquid specific protein (lsp) calibrator lot-specific instructions for use (ifu) for calibrator kit lot 303574 resided on the siemens document library from december 10, 2013 until april 7, 2014. the lsp calibrator ifu version that resided on the siemens document library during this time contained preliminary calibrator values that differed slightly from the final calibrator values for the following advia chemistry systems assays: aag, aat, aso_2, c3, c4, frt, hapt, iga_2, igg_2, igm_2, prealb, rf and trf.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens Advia Liquid Specific Protein (LSP) Calibrator

Manufacturer

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