Events

Retiro De Equipo (Recall) de IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi

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
    69588
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0212-2015
  • Fecha de inicio del evento
    2014-10-20
  • Fecha de publicación del evento
    2014-11-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130998
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Causa
    A typographical error regarding the expiration date was identified in the control module instructions for use.
  • Acción
    Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction letter October 17, 2014, to US customers, and an Urgent Field Safety Notice issued October 16, 2014, outside the US. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to review the notice with their medical directors. Customers should discard the control module IFU listed in table 1 and refer to table 2 for the list of revised IFU versions as noted on the notice. Finally, the customers should check the system for the expiration date and if correct, no further action is required. Field Correction Effectiveness Check should be returned via fax (312) 275-7795 within 30 days. For further questions please call 914-631-8000.

Device

IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi
  • Modelo / Serial
    Catalog Number: LCLCM, Lot Number: 0019, Siemens Material Number: 10385383, IFU Reference: PILCLCM-11 {24}, 2014-02-19; PINLCLCM-11{24}, 2014-02-19; PIELCLCM-9{24}, 2014-02-19
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution including the states of FL, KY, MN, MA, PA, UT, NY, VA and CA., and the countries of Algeria, Australia, Argentina, Austria, Belgium, Brazil, Bulgaria, Cameron, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Latvia, Macedonia, Mexico, Netherlands,Pakistan, Peru, Poland, Portugal, Rep. Korea, Romania, Russian Fed, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tadjikistan, Taiwan,Turkey, Unit. Arab Emir and Vietnam.
  • Descripción del producto
    IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) || For in vitro diagnostic use with IMMULITE¿ Systems Analyzers  for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
  • 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