Events

Retiro De Equipo (Recall) de Device Recall HerpeSelect 1 and 2 Immunoblot IgG 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 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
    47459
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1764-2008
  • Fecha de inicio del evento
    2007-07-06
  • Fecha de publicación del evento
    2008-08-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-06-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69534
  • 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
    Enzyme Linked Immunoabsorbent Assay - Product Code LGC
  • Causa
    A small percentage of samples tested in specific lots, the hsv common antigen band appears lighter (less reactive) than the reading control band. reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative.
  • Acción
    Focus notified all clients which received the recalled lots starting on July 6, 2007 via an Important Medical Device Information letter by fax or email. The letter explains how to identify suspect results and the steps to be taken if suspect results are obtained. If customers find the interpretation of results with the indicated kit lots to be problematic, customers have the option of having their kits replaced at no charge within 90 days of receiving the notification.

Device

Device Recall HerpeSelect 1 and 2 Immunoblot IgG Kit
  • Modelo / Serial
    Lot Codes 063169 (Expires December 2007), 063354 (Expires October 2007), 063355 (Expires July 2007)
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including states of OH, CA, CT, IL, NY, and countries of Barbados, Canada, Germany, Israel, Slovakia, France, and England.
  • Descripción del producto
    HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G || Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera.
  • Manufacturer
    Focus Diagnostics Inc

Manufacturer

Focus Diagnostics Inc
  • Dirección del fabricante
    Focus Diagnostics Inc, 10703 Progress Way, Cypress CA 90630-4714
  • Source
    USFDA