Events

Retiro De Equipo (Recall) de UniCel DxH 800 Coulter Cellular Analysis System

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
    Recall
  • ID del evento
    58584
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2227-2011
  • Fecha de inicio del evento
    2011-04-14
  • Fecha de publicación del evento
    2011-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99629
  • 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
    Differential Cell Counter - Product Code GKZ
  • Causa
    The recall was initiated because beckman coulter has confirmed the auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old.
  • Acción
    The recall communication was initiated on 4/12/11 with Beckman Coulter forwarding an Urgent Product Correction (PC) letter with attached PC Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel¿ DxH" 800 Coulter¿ Cellular Analysis System PN 629029. The letter provides customers with an explanation of the problem identified and an action to be taken. For Issue 1 & 2, customers were instructed to perform manual database maintenance procedures to locate and delete unnecessary patient result and demographic information that extends beyond the life (in days) of the control lots. Ensure an alternative method of analysis is available during database maintenance. For Issue 3, customers were instructed to not attempt to transmit the files again after receiving an incomplete report. Instead, submit the missing file(s) by one of the following methods: - Submit your data at the electronic IQAP website (eIQAP) at (http://www.beckmancoulter.com/qap/index.jsp) - Fax printouts of the missing files to 786-639-3999 - Email an electronic copy (.CSV) of the control file to IQAP.Reports@beckman.com. - Include the IQAP number on any communication. A corrected report will be returned to the customers' laboratories. For issue 4, customers were instructed to submit their control data to IQAP by one of the following methods: -Submit their data at the electronic IQAP website (eIQAP) at (http://www.beckmancoulter.com/qap/index.jsp) -Fax printouts of the missing files to 786-639-3999 -Email an electronic copy (.CSV) of the control file to IQAP.Reports@beckman.com. -Include your IQAP number on any communication. Customers were instructed to complete and return the enclosed Response Form within ten days. Customers 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.

Device

UniCel DxH 800 Coulter Cellular Analysis System
  • Modelo / Serial
    Part # 629029
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, Canada, Australia, Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
  • Descripción del producto
    Unicel¿ DxH 800 Coulter¿ Cellular Analysis System. || A quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

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