Events

Retiro De Equipo (Recall) de Device Recall Rheumatoid Factor (RF) Kit for use on SPAPLUS

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
    78934
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0553-2018
  • Fecha de inicio del evento
    2018-01-04
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160910
  • 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, rheumatoid factor - Product Code DHR
  • Causa
    The low and high controls for the product are returning results above the assigned values.
  • Acción
    Binding Site sent an Urgent Field Safety Notice dated December 22, 2017. Advise on action to be taken by the User: " The new QC values detailed below should be used for the remainder of the shelf life of this Rheumatoid Factor Kit for use on SPAPLUS. "Input the revised QC values into your SPAPLUS instrument "Sign and return the TSWS18 E-Back Form accompanying this notification within 5 business days "Refer to Section 9 of the Product Insert SIN282(.A) if QCs are out of range following reassignment. For further questions, please call (858) 453-9177.

Device

Device Recall Rheumatoid Factor (RF) Kit for use on SPAPLUS
  • Modelo / Serial
    Lot #416595, Exp. 31/03/2018; UDI #05051700018319
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution was made to CA. There was no foreign/military/government distribution.
  • Descripción del producto
    Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A || Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings
  • 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