Events

Retiro De Equipo (Recall) de DIMENSION CLINICAL CHEMISTRY SYSTEM - IRON FLEX REAGENT CARTRIDGE

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
    99319
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-09-02
  • 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 deferoxamine interference with dimension and dimension vista iron assays at a different concentration than listed in the instructions for use (ifu). deferoxamine is listed in the dimension and dimension vista ifu's as a non-interfering substance. the concentration that was used for interference testing (250 ng/dl or 3.8 nmol/l) is significantly below what would be expected in clinical practice. siemens healthcare diagnostics is providing an update to the limitation of procedure section for the dimension and dimension vista iron assays instructions for use (ifu) to indicate that: patients treated with metal-binding drugs (e.G. deferoxamine) may have depressed iron values as chelated iron may not properly react in the iron assay.

Device

DIMENSION CLINICAL CHEMISTRY SYSTEM - IRON FLEX REAGENT CARTRIDGE
  • Modelo / Serial
    Model Catalog: DF85 (Lot serial: All Lots); Model Catalog: K3085 (Lot serial: All Lots)
  • Descripción del producto
    DIMENSION CLINICAL CHEMISTRY SYSTEM - IRON FLEX REAGENT CARTRIDGE;DIMENSION VISTA SYSTEM - IRON ASSAY;DIMENSION XPAND SYSTEM - IRON (IRON) ASSAY;DIMENSION EXL SYSTEM - IRON (IRON) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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