Retiro De Equipo (Recall) de Device Recall VITROS Chemistry Products Digoxin (DGXN) Slides

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 Ortho-Clinical Diagnostics.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 immunoassay, digitoxin - Product Code LFM
  • Causa
    Ortho clinical diagnostics revised the vitros chemistry products dgxn slides instructions for use (ifu) and removed heparin plasma as a recommended specimen type for vitros dgxn slides.
  • Acción
    Ortho Clinical Diagnostics sent an Urgent Field Safety Notice dated June 28, 2012, via US Postal Service Priority Mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: Immediately discontinue using heparin plasma samples and use only serum samples when processing VITROS DGXN Slides; Notify their laboratory and medical staff of this change and forward the information if the product have been distributed outside of your facility; Replace the pages of their VITROS Instructions for Use Manual with the enclosed Instructions for Use and Table of Contents; and Discontinue using any copies of the VITROS¿ DGXN Slide IFU (Version 7.0).--- On 28 June 2012 an Urgent Field Safety Notice was sent via US Postal Service Priority Mail to all affected Distributors. They were advised of the issue and instructed to discontinue distributing and discard their remaining inventory of VITROS DGXN Slides. --- Foreign affiliates were informed by email on 28 June 2012 of the issue and instructed to notify their consignees of the issue and actions. The letters included a Confirmation of Receipt form to be completed and return. For questions contact Customer Technical Servives at 1-800-421-3311


  • Modelo / Serial
    Lots from coating 0204, 0205, 0206. A Coating (CTG) is a unique identifier within the Lot Number of some of OCDs products
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US (nationwide)
  • Descripción del producto
    VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. || Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer


  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
  • Source