Retiro De Equipo (Recall) de COULTER Ac"T" 5diff Fix 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
  • 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
    Products, red-cell lysing products - Product Code GGK
  • Causa
    The recall was initiated because beckman coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the coulter a t 5 diff pn 8547171.
  • Acción
    Beckman Coulter initiated a Product Corrective Action (PCA) letter on April 8, 2011, with attached PCA Response Form to all customers who purchased the COULTER¿ Ac"T" 5diff Fix Reagent. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discard the product according to their laboratory safety procedures and use the attached response form to request replacement product. All flagged results should be reviewed as outlined in the Instructions for Use manual and your laboratory protocol. A retrospective review of results is not required if all recommendations for review have been followed as shown in the Instructions for Use. Customers were instructed to share the information with their laboratory staff and to retain the notification as part of their Quality System documentation. If the product was further distirbuted to another laboratory, customers should provide them a copy of the notification letter. The raw material issue has been corrected beginning with COULTER¿ A T 5diff Fix lot 16902E. Customers were instructed to complete and return the enclosed Response Form within ten (10) days. Customers with any questions concerning this notice, were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.


  • Modelo / Serial
    Lot # 16602E, 16702E, 16802E
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Botswana, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Guyana, Italy, Japan, Kenya, Mexico, Morocco, Namibia, Netherlands, Nigeria, Philippines, Puerto Rico, Russian Federation, Slovakia, South Africa, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Zambia
  • Descripción del producto
    COULTER¿ Ac"T" 5diff Fix Reagent. || Part Number: 8547171 || COULTER¿ AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on COULTER Ac"T 5diff hematology analyzers. Intended for use only with specific Ac"T 5diff reagents. Refer to the instrument product manuals and/or online help, as applicable.
  • Manufacturer


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