Events

Retiro De Equipo (Recall) de West Nile Virus IgG DxSelect

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 Focus 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
    63387
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0182-2013
  • Fecha de inicio del evento
    2012-10-03
  • Fecha de publicación del evento
    2012-10-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113653
  • 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
    Elisa, antibody, west nile virus - Product Code NOP
  • Causa
    The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
  • Acción
    Focus Diagnostics Inc., sent a Urgent Medical Device Recall letter dated October 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you received at least one of the effected lots in the month of August 2012. Please document the number of kits in your inventory on the table below, even if zero (0), and fax to 562-240-6526. For further questions please call (714) 220-1900.

Device

West Nile Virus IgG DxSelect
  • Modelo / Serial
    Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117.
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
  • Descripción del producto
    West Nile Virus IgG DxSelect" kit Catalog No. EL0300G || Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen || Wells, Catalog Number EL0351, Lot Number 121117. || 510(k) No. K031953 || The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
  • Manufacturer
    Focus Diagnostics Inc

Manufacturer

Focus Diagnostics Inc
  • Dirección del fabricante
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source
    USFDA