Events

Retiro De Equipo (Recall) de Device Recall Optilite Analyser

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 The Binding Site Group, Ltd..

¿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
    75898
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1018-2017
  • Fecha de inicio del evento
    2015-05-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151646
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Potential risk of the optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
  • Acción
    Binding Site sent an Urgent Field Safety Notice letter dated May 13, 2015 to their customers The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the Eback Form that this notice has been received and the actions to be taken have been completed to technical.services@bindingsite.co.uk

Device

Device Recall Optilite Analyser
  • Modelo / Serial
    864000290243  864000290832 864000290244  864000290833 864000290330  864000290834 864000290447  864000290836 864000290448  864000290837 864000290449  864000290838 864000290452  864000290844 864000290826  864000290845 864000290827  864000290846 864000290828  864000290847 864000290831  864000290850
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: CA, VA, GA, PA, NJ, KY, NY, AR, NM, NC, AL, GA, MI, and the countries of Canada, China, Australia, Israel, Ireland, UK, Germany, Belgium, Italy, France, Czech republic, Spain, Portugal.
  • Descripción del producto
    Optilite Analyser, Product Code: IE700 || Product Usage: || The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.
  • Manufacturer
    The Binding Site Group, Ltd.

Manufacturer

The Binding Site Group, Ltd.
  • Dirección del fabricante
    The Binding Site Group, Ltd., 8 Calthorpe Road, Birmingham United Kingdom
  • Empresa matriz del fabricante (2017)
    Cidron Iugo Sarl
  • Source
    USFDA