Retiro De Equipo (Recall) de Device Recall UniCel DxI 800 Access Immunoassay Systems

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
    Analyzer chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    The recall was initiated due to beckman coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. the first rack of the two was not scanned. this is referred to as a "pushed pair." if a pushed pair event occurs, results may be associated with the incorrect patient identification.
  • Acción
    Beckman Coulter sent an Urgent: Field Safety Notice Product Correction letter dated January 26, 2011, via US Postal Service to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: 1. To prevent a pushed pair, be sure your sample racks are free of debris prior to use. Do not apply additional labels to the sample racks. Extra labels can obscure the edges of a sample rack, or obstruct the gap between two racks. Be sure sample labels do not extend beyond the edges of a sample rack; 2. If a pushed pair occurs on the UniCel DxI system, the system generates a yellow Event Log message - Clear the presentation tray and press ROUTINE button. This Event Log message is associated with a variety of common Sample Presentation Unit (SPU) errors. For that reason, you must review the Event Log details to confirm the pushed pair event has not occurred; 3. Detach the Appendix included with this notification and store it near your UniCel DxI system. Use the Appendix as a reference if you suspect a pushed pair event has occurred on your system. Beckman Coulter also requested their customers share the recall information with their laboratory staff, and retain pages 1 and 2 of this notification as part of your laboratory Quality System documentation. For questions regarding ththe recall notification, customers were instructed to contact Beckman Coulter Customer Support Center on the Beckman Coulter website at, or call 1-800-854-3633 in the United States or Canada. Outside the United States and Canada, contact their local Beckman Coulter Representative.


  • Modelo / Serial
    DxI System Software versions: 2.3, 2.4, 4.1, 4.2.1, 4.3 (Current released version), 4.3.2 (Released to a single Japanese customer only)
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
  • Descripción del producto
    UniCel DxI 800 Access Immunoassay || Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured || A25288, DxI 800 with spot B A71456, DxI 800 || Reconditioned A25285 || The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
  • Manufacturer


  • Dirección del fabricante
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Empresa matriz del fabricante (2017)
  • Source