Retiro De Equipo (Recall) de Device Recall VITROS Immunodiagnostic Products CA 199 Reagent Pack and CA 199 Calibrators

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
    System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
  • Causa
    Customers may receive positively biased results when using vitros¿ immunodiagnostic products ca 19-9 total reagent packs, lot 1320 and vitros¿ ca 19-9 calibrators, lot 1320 on the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system. there is an unexpected observed change in ca 19-9 calibrators, lot 1320 calibrator values.
  • Acción
    Ortho Clinical Diagnostics sent an Urgent Product Correction Notification July 2014 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to Immediately discontinue using and discard Lots 1320 of VITROS CA 19-9 Calibrators and Reagent Packs. Review previously reported VITROS 25-OH Vitamin D Total results using Lot 1320. Review quality control results used to verify calibration events. Results lower than the target mean may indicate potentially biased assay results. Discuss any concerns regarding previously reported results with the Laboratory Medical Director or with the requesting physician. Complete and return the attached Confirmation of Receipt form. OCD will: credit their account for all VITROS¿ CA 19-9 Calibrators and Reagent Packs that were discarded or ship repalcment product uspon request. Customers were instructed to forward the information in this notification if they have distributed this product outside of their facility. Customers with questions were instructed to contact their Customer Technical Service representative or contact the Customer Technical Service representative at 1-800-421-3311.


  • Modelo / Serial
    Lot 1320, Product code: 6800035 and 6800040
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to France and Japan
  • Descripción del producto
    VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 || VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.
  • Manufacturer


  • Dirección del fabricante
  • Empresa matriz del fabricante (2017)
  • Source