Events

Retiro De Equipo (Recall) de Human IgG Subclass Liquid Reagent Kit

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
    76041
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1070-2017
  • Fecha de inicio del evento
    2014-09-11
  • Fecha de publicación del evento
    2017-01-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152027
  • 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
    Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
  • Causa
    Customer complaints identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results.
  • Acción
    Binding Site sent an Important Information letter dated September 30, 2014, Customers were instructed to retain the notification for records and additional instructions with the firm stating they were updating the instructions for use. Customers with questions were advised to contact their Binding Site representative or technical.service@bindingsite.co.uk.

Device

Human IgG Subclass Liquid Reagent Kit
  • Modelo / Serial
    All lots.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including n FL, OH, TN, MN, NW, MI, CA. and Internationally to Canada, France, UK, Spain, Germany, Czech Republic, Belgium, Italy, Australia, Brazil, Chile, China, Costa Rica, Kuwait, New Zealand, Oman, Pakistan, Portugal, Sweded, Taiwan, and Turkey.
  • Descripción del producto
    Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser || Product Code: NK009.T || This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
  • 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