Retiro De Equipo (Recall) de Device Recall SYNCHRON Systems Calibrator 1

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
  • 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
    Calibrator, multi-analyte mixture - Product Code JIT
  • Causa
    The recall was initiated because standardization of the synchron systems calibrator 1, used for both the synchron lx and unicel dxc systems, has been established to the new ifcc reference preparation for plasma proteins, erm-da470k (formerly cr470) beginning with lot number m005558. during the standardization to the new ifcc standard, erm-da470k, we confirmed that complement c4 (c4) had been re.
  • Acción
    Beckman Coulter initiated a Product Corrective Action (PCA) letter on the week of March 14, 2011, to the affected customers. Though Beckman is recalling the LX Cal 1, the recall letter was sent to the C4 reagent customers, as these are the only customers who will be impacted by the problem noted in the PCA letter. The letter provided the customers with an explanation of the problem identified and an action to be taken. The letter recommended consignees take the following actions: (1)Notify their clients to review and evaluate the impact on patients whose Complement C4 recovered near the clinical decision points. (2) Re-evaluate their laboratory's reference ranges for C4. The letter further requested that consignees share this information with laboratory staff and retain this notification as part of your laboratory Quality System documentation. Questions regarding this Product Announcement letter, or requests for the correlation graphs should be directed to Customer Support Center (Call Center) on the Beckman Coulter website at Support/Support Request or call (800) 854-3633 in the United States and Canada.


  • Modelo / Serial
    Lots prior to M005558
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Eritrea, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Poland, Puerto Rico, Qatar Reunion, Russian Federation, Rwanda, Serbia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Viet Nam
  • Descripción del producto
    SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 || The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibration of immunoprotein tests on SYNCHRON LX and UniCel DxC Systems.
  • Manufacturer


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