Events

Retiro De Equipo (Recall) de IMMULITE/IMMULITE 1000 ThyroxineBinding Globulin

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
    71006
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1629-2015
  • Fecha de inicio del evento
    2015-04-09
  • Fecha de publicación del evento
    2015-05-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135838
  • 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
    Radioimmunoassay, thyroxine-binding globulin - Product Code CEE
  • Causa
    Immulite/immulite 1000 tbg catalog lktb lot 257 is failing the adjustment slope instrument parameter of <1.80. the resulting slope of the kit is >1.80 resulting in the potential to produce depressed tbg patient values.
  • Acción
    Siemens sent an Urgent Field Safety Notice dated April 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer Discontinue use and discard kit lot listed in Table 1. Review your inventory of these products to determine your laboratory's replacement needs. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within thirty (30) days. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions call (914) 631-8000.

Device

IMMULITE/IMMULITE 1000 ThyroxineBinding Globulin
  • Modelo / Serial
    LOT 0257, SMN 10381643
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution to the countries of : Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China and Russian Federation.
  • Descripción del producto
    IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 || Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.
  • 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