Events

Retiro De Equipo (Recall) de ADVIA 1200 CHEMISTRY SYSTEM - FRUCTOSAMINE (FRUC) REAGENT

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
    39406
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-03-24
  • 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 healthcare diagnostics has become aware of n-acetylcysteine (nac) and metamizole (dipyrone) interference with trinder and trinder-like reaction assays. the trinder reaction is a reaction where hydrogen peroxide is formed and subsequently reacts with a phenol derivative and aminoantipyrine in the presence of peroxidase to form a coloured quinone product. siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving n-acetylcysteine (nac) or metamizole. nac is the accepted antidote for acetaminophen toxicity and is justified in patients at significant risk for hepatotoxicity. metamizole is an anti-inflammatory anti-pyretic drug banned in most countries because of the potential for nephrotoxicity. the instructions for use (ifu) for the assays will be updated to indicate that: venipuncture should occur prior to n-acetylcysteine (nac) or metamizole administration due to the potential for falsely depressed results.

Device

ADVIA 1200 CHEMISTRY SYSTEM - FRUCTOSAMINE (FRUC) REAGENT
  • Modelo / Serial
    Model Catalog: 10361941 (Lot serial: all lots); Model Catalog: 04862501 (Lot serial: all lots); Model Catalog: 04992596 (Lot serial: all lots); Model Catalog: 10376501 (Lot serial: all lots); Model Catalog: 07497014 (Lot serial: all lots); Model Catalog: 03051305 (Lot serial: all lots); Model Catalog: 10335892 (Lot serial: all lots); Model Catalog: 07109944 (Lot serial: all lots); Model Catalog: B01-4818-01 (Lot serial: all lots); Model Catalog: 09796248 (Lot serial: all lots); Model Catalog: B01-4760-01 (Lot serial: all lots); Model Catalog: 07511947 (Lot serial: all lots); Model Catalog: 06521559 (Lot serial: all lots); Model Catalog: 10335872 (Lot serial: all lots); Model Catalog: 10697575 (Lot serial: all lots); Model Catalog: 10492319 (Lot serial: all lots); Model Catalog: 04993681 (Lot serial: all lots); Model Catalog: 04993452 (Lot serial: all lots); Model Catalog: 04993223 (Lot serial: all lots)
  • Descripción del producto
    ADVIA 1200 CHEMISTRY SYSTEM - FRUCTOSAMINE (FRUC) REAGENT;ADVIA CHEMISTRY SYSTEM - ENZYMATIC CREATININE_2 (ECRE_2) ASSAY;ADVIA 1200 CHEMISTRY SYSTEM - CHOLESTEROL_2 (CHOL_2) ASSAY;ADVIA CHEMISTRY SYSTEM - URIC ACID (UA) ASSAY;ADVIA 1200 CHEMISTRY SYSTEM -
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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