Retiro De Equipo (Recall) de SYNCHRON Systems Microalbumin (MA) Reagent

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 Beckman Coulter 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio 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
    Albumin, antigen, antiserum, control - Product Code DCF
  • Causa
    Beckman coulter has confirmed that ma reagent lot m609458 may recover outside the lower limit of the published insert range for beckman coulter urine protein control level 1.
  • Acción
    Beckman Coulter sent an Urgent Medical Device Recall letter dated April 24, 2017, to affected customers to inform them that Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1. Internal testing has confirmed that MA is recovering within the published insert range for Beckman Coulter Urine Protein Control Level 2. Customers are informed of the impact, actions to be taken, and resolution. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to Customer Support Center via, call 1-800-854-3633 in the United States and Canada, and outside US and Canada they are instructed to contact their local Beckman Coulter Representative.


  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Guatemala, India, Italy, Japan, Mayotte, Mexico, Netherlands, Oman, Philippines, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.
  • Descripción del producto
    Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL || MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
  • Manufacturer


  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
  • Source