Events

Retiro De Equipo (Recall) de Device Recall IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress

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, Inc..

¿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
    71363
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1843-2015
  • Fecha de inicio del evento
    2015-05-06
  • Fecha de publicación del evento
    2015-06-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137452
  • 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
    System, test, radioallergosorbent (rast) immunological - Product Code DHB
  • Causa
    Immulite 2000/2000xpi italian cypress (t23l4), lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label.
  • Acción
    Siemens Healthcare Diagnostics issued an Urgent Medical Device Recall Letter (IMC-15-11A.US, dated May 6, 2015) in the US via FedEx, and an Urgent Field Safety Notice (IMC-15-11A.OUS, May 2015) outside the US on May 6, 2015. Customers were instructed to immediately discontinue use of and discard IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 206. The shelf-life of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 208, has been shortened to June 30, 2015. Discontinue use and discard lot 208 after June 30, 2015. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within 30 days in the US and OUS and fax to Customer Care Center at 312-275-7795.

Device

Device Recall IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress
  • Modelo / Serial
    Kit lots 206 (exp. 6-30-2015) and 208 (exp. 11-30-2015)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-Distributed in the states of Florida, New Mexico and New York and the countries of Australia, Belgium, Chile, Costa Rica, Croatia, Czech Republic, France, Germany, Greece, Guatemala, Israel, Italy, Japan, Kazakhstan, Latvia, Netherlands, Portugal, Romania, Russian Federation, Slovakia, and Spain.
  • Descripción del producto
    IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. || For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA