Retiro De Equipo (Recall) de Device Recall Access Immunoassay Systems Estradiol

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
    radioimmunoassay, estradiol - Product Code CHP
  • Causa
    The recall was initiated after beckman coulter confirmed that three lots of access estradiol reagent (ref 33540) contains an incorrect raw material which may produce incorrect patient results.
  • Acción
    A Product Corrective Action (PCA) letter dated March 17, 2010, with attached PCA Customer Response Form was sent to the affected customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of the three Access Estradiol Reagent lots; discard all remaining inventory of affected product; share this information with laboratory staff and retain the notification as part of their laboratory Quality System documentation, and complete and return the enclosed response form within 10 days via fax to 786-639-4000 or mail: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs. The following product replacement contacts were provided: In the United States, please contact Client Services at 1-800-526-3821. In Canada, please contact Customer Service at 1-800-463-7828. Outside the United States and Canada, contact your local Beckman Coulter Representative. Questions and assistance could be obtained through Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.


  • Modelo / Serial
    Lot Numbers: 913016 (exp. 6/20/2010), 915171 (exp. 10/30/2010), 917766 (exp. 12/21/2010)
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA and Internationally to: Algeria, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, El Salvador, France, Georgia, Germany, Ghana, Greece, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Oman, Panama, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab, United Kingdom, Venezuela, Vietnam, and Zambia
  • Descripción del producto
    Access Immunoassay Systems Estradiol, Part Number: 33540 || Intended use: The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum and plasma using the Access Immunoassay systems.
  • Manufacturer


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