Events

Retiro De Equipo (Recall) de EnVision FLEX, EnVision FLEX, EnVision FLEX Mini 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 Dako North America 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
    72097
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0220-2016
  • Fecha de inicio del evento
    2015-09-04
  • Fecha de publicación del evento
    2015-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139936
  • 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
    Reagent, general purpose - Product Code LDT
  • Causa
    There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.
  • Acción
    Dako sent an customer notification letter on September 4, 2015, to all affected customers via mail. The letter identified the product the problem and the action needed to be taken by the customer. The customers/distributors are instructed in the Recall Notification Letters to 1) remove any unused kits bearing the affected lot numbers listed in their letter from diagnostic use 2) destroy any unused kits bearing the affect lot numbers listed in their letter, and 3) determine any possible impact of this change in performance on patient results from the affected lots. The letter states actions should be taken within 10 days and that customers/distributors should confirm they have received the information by returning the attached, fully completed Device Recall Form and return it to Dako QA Vigilance by email at dako.dkvigilance@dako.com. The firm lists on their letter for customers to contact their Dako representative in there are any questions. For further questions, call (805) 566-6655.

Device

EnVision FLEX, EnVision FLEX, EnVision FLEX Mini Kit
  • Modelo / Serial
    Item No.: K800021-2, K800221-2, K802321-2 (Link) K801021-2, K801221-2, K802421-2 (AS/AS+) GV80011-2, GV82311-2 (Dako Omnis)  Catalog/Model No.: K8000 K8002 K8023 GV800  SM802 EnVision FLEX / HRP Lot 20019374 used in: Envision FLEX, High pH (link) Lot No.: 20019097, 20020777, 20021381 Envision FLEX+, Mouse, High pH (link) Lot No.: 20019103, 20019113, 20020772 EnVision FLEX Mini Kit, High pH (Link) Lot No.: 20021362  DM 842 EnVision FLEX / HRP (Dako Omnis) Lot 20019013 used in: EnVision FLEX, High pH (Dako Omnis) Lot No.: 20019102
  • Distribución
    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the states of : TX, SD, CA, FL, MA, MD, WV, NC, OH, DE, MI, NJ, CO, HI, AR, NY, LA, GA, NV, RI, IL, OK, CT, MO, VA, and DC., and to the countries of : Canada, Brazil and Costa Rica.
  • Descripción del producto
    EnVision FLEX/HRP visualization reagent found in the following kits: || EnVision FLEX, High pH (Link) || EnVision FLEX+, Mouse, High pH (Link) || EnVision FLEX Mini Kit, High pH (Link) || EnVision FLEX, High pH (Dako Omnis) || Multi-component, sealed package. For in vitro diagnostic use.
  • Manufacturer
    Dako North America Inc.

Manufacturer

Dako North America Inc.
  • Dirección del fabricante
    Dako North America Inc., 6392 Via Real, Carpinteria CA 93013-2921
  • Empresa matriz del fabricante (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA