Retiro De Equipo (Recall) de Device Recall Abbott CELLDYN 3000CS (Closed Sampler), CELLDYN 3000SL (Sample Loader)

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 Abbott Laboratories.

¿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
    Counter, differential cell - Product Code GKZ
  • Causa
    Expanded recall to include these additional products: fire hazard-- some power supply modules may have incorrect fuses installed, which may result in fires and smoking.
  • Acción
    Abbott Laboratories sent Product Correction letters, dated March 22, 2010, to its customers. The letter listed the additional products that are now included in the recall and gave an explanation of the reason for recall. The letter also discussed the safety impact and provided a list of necessary actions for customers. Customers are to check that the ampere rating of the fuse matches the voltage of operation that is currently being utilized with their CELL-DYN 3000 Analyzer. If the fuse is correct, then the steps provided should be followed. If the fuse is incorrect, then customers are to replace the fuse with the correct fuse and follow the instructions provided. Customers are to contact their local Customer Support Representative in the event that they do not have their replacement fuse that was provided with the Accessory Kit. Customers can refer to the Product Information Letter dated April 20, 2010 for additional labeling to assist with the correct fuse replacement. The Customer Reply form should be completed and the letter should be kept with the Operator's Manual. Questions should be directed to Customer Support at 1-877-4ABBOTT. The firm, Abbott Laboratories, sent a "Product Correction" letter dated March 27, 2009 to its customers. The letter included a Customer Reply form and CELL-DYN accessory kits to inform new customers of the necessity of replacing fuses correctly. The letter described the product, problem and actions to be taken. The customers were instructed to check that the ampere rating of the fuse matches the voltage of operation that is currently being utilized with their CELL-DYN 3700 System and follow the instructions provided, and complete and return the Customer Reply form via fax to 1-800-777-0051 or e-mail, even if they no longer have the instrument. The firm intends to service items in the field. In April 2010, additional labeling was sent to customers providing additional information when replacing fuses.


  • Modelo / Serial
    List numbers: 03H53-01, 03H53-03, CELL-DYN 1700 List numbers: 03H57-01, 03H57-03, CELL-DYN 1700 CS. All serial numbers
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- USA, including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Dominica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand Trinidad and Tobago, Turks & Caicos, Uruguay, and Venezuela.
  • Descripción del producto
    Abbott CELL-DYN 1700 Analyzer, CELL-DYN 1700 CS (Closed Sample).Manufactured by Abbott Diagnostics Division, Santa Clara, Ca || Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories.
  • Manufacturer


  • Dirección del fabricante
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source