Events

Retiro De Equipo (Recall) de ADVIA 1200 CHEMISTRY SYSTEM - LIQUID SPECIFIC PROTEIN CALIBRATORS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE 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
    78920
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-11-06
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Siemens health care diagnostics has confirmed two issues with the siemens liquid specific protein calibrator lot 303574. issue 1: 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 (att) assay. the max fit deviation flag impacts the level 2 calibrator (123it) for the advia chemistry systems aat assay. issue 2: siemens confirmed that the preliminary version of the siemens lsp calibrator lot-specific instructions for use (ifu) for calibrator kit lot 303574 resided in the siemens document library from dec.10 2013 until apr.07 2014. the lsp calibrator preliminary factor values during this time differed slightly from the final factor values for the following advia chemistry stystem assays: aag aat aso_2 c3 c4 frt hapt iga_2 igg_2 igm_2 prealb rf and trf. the ifu insert packaged in the siemens lsp calibrator kit lot 303574 always contained the correct values for all those assays except aat. the ifu that is currently in the kit and the ifu that was in the siemens document library from apr.07 2014 to oct.30 2014 does not reflect the updated aat calibrator value for lsp calibrator level 2. as of oct.31 2014 all of the final lsp calibrator values are correct on the siemens document library. when using either the final or preliminary calibrator values quality control results recover well within the manufacturer's specified upper and lower ranges and patient sample results did not demonstrate clinically significant differences.

Device

ADVIA 1200 CHEMISTRY SYSTEM - LIQUID SPECIFIC PROTEIN CALIBRATORS
  • Modelo / Serial
    Model Catalog: 07711199 (Lot serial: 303574)
  • Descripción del producto
    ADVIA 1200 Chemistry System - Liquid Specific Protein Calibrator
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC