Events

Retiro De Equipo (Recall) de ADVIA 1200 CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE L-P (LDLP) ASSAY

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
    34792
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-02-13
  • 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 is providing an update to all advia chemistry systems lactate dehydrogenase l-p (ldlp) and lactate dehydrogenase p-l (ldpl) assay instructions for use (ifus). the current advia chemistry systems lactate dehydrogenase ifus intended use section contains the following statements which will be removed: advia chemistry ldlp: they may also be used to monitor cancer therapy. advia chemistry ldpl: they may also be used to monitor extensive cancer and cancer therapy. the revised ifu intended use for both assays are listed below: advia chemistry ldlp: for in vitro diagnostic use in the quantitative determination of lactate dehydrogenase activity in human serum and plasma on advia chemistry systems. such measurements are used mainly in the diagnosis and treatment of myocardial and pulmonary infarction. advia chemistry ldpl: for in vitro diagnostic use in the quantitative determination of lactate dehydrogenase activity in human serum and plasma on advia chemistry systems. such measurements are used mainly in the diagnosis and treatment of myocardial and pulmonary infarction.

Device

ADVIA 1200 CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE L-P (LDLP) ASSAY
  • Modelo / Serial
    Model Catalog: 07502115 (Lot serial: ALL); Model Catalog: 03029628 (Lot serial: ALL); Model Catalog: 03030863 (Lot serial: ALL); Model Catalog: 07502999 (Lot serial: ALL)
  • Descripción del producto
    ADVIA 1200 CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE L-P (LDLP) ASSAY;ADVIA 1200 CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE P-L (LDPL) ASSAY;ADVIA CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE P-L (LDPL) ASSAY;ADVIA CHEMISTRY SYSTEM - LACTATE DEHYDROGENASE L-P (L
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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