Events

Retiro De Equipo (Recall) de Device Recall IMMULITE/IMMULITE 1000 CKMB

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Siemens Healthcare Diagnostics.

¿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
    61029
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1271-2012
  • Fecha de inicio del evento
    2012-01-25
  • Fecha de publicación del evento
    2012-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107122
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Fluorometer method, cpk or isoenzymes - Product Code JHX
  • Causa
    Siemens healthcare diagnostics has observed that the median for the reference range with current kit lots of the ck-mb assay differs from the guidelines published in the instructions for use (ifu). this difference applies to all immulite platforms.
  • Acción
    Siemens sent an "URGENT DEVICE RECALL" letter dated January 2012 to all affected customers. The letter identifies the product , problem, and actions to be taken by the customers. Siemens recommends that customers reestablish their own medians and reference ranges, in line with the recommendations made in the IFU for these products. A Field Correction Effectiveness Check form was included for customers to complete and return to the firm. Customers with questions or who need additional information should contact their Siemens Technical Solutions Center.

Device

Device Recall IMMULITE/IMMULITE 1000 CKMB
  • Modelo / Serial
    kit lot 312, 313
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    IMMULITE¿/IMMULITE¿ 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500 tests) --- Test code: CMB Color: Dark Blue. || For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA