Events

Retiro De Equipo (Recall) de Veridex

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 Veridex, LLC.

¿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
    38206
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1102-2007
  • Fecha de inicio del evento
    2007-04-17
  • Fecha de publicación del evento
    2007-07-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-12-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53161
  • 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
    in vitro diagnostic - Product Code NQI
  • Causa
    An increased incidence of aggregates was observed in lot 0036 and 0036a. the presence of aggregates will cause customers to invalidate patient results.
  • Acción
    All Direct customers and customers of distributors received a customer notification informing them of the increased incidence of aggregates in cartridges on April 30, 2007 by Fed Ex overnight. This letter instructed them to discontinue use and to discard any remaining inventory. This was followed by a notification on May 24, 2007 by Fed Ex overnight to all US Distributors which also requested that they immediately stop using and/or distributing kits and to destroy any remaining inventory. Distributors were also asked to notifiy customers who received product. All foreign affiliate consignees were also informed on this date by e-mail and instructed to notify their customers.

Device

Veridex
  • Modelo / Serial
    Ref 7900001, Lot 0036 Ref 7900000, Lot 0036A - This is a research use only lot and not for in vitro diagnostic use.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The kits were distributed to hospitals and laboratories nationwide. They were also sent to 7 J&J; affiliated companies in France, Japan, Canada, England, Germany, Italy and Spain.
  • Descripción del producto
    Cell Search Circulating Tumor Cell Kit (Epithelial) || Veridex LLC, a Johnson & Johnson Company || IVD || Veridex, LLC || 33 Technology Drive || Warren, NJ 07059 USA || 1-877-VERIDEX USA
  • Manufacturer
    Veridex, LLC

Manufacturer

Veridex, LLC
  • Dirección del fabricante
    Veridex, LLC, 33 Technology Dr, Warren NJ 07059-5148
  • Source
    USFDA