Retiro De Equipo (Recall) de COULTER LH 500 Series 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
    44916
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0314-2008
  • Fecha de inicio del evento
    2007-04-18
  • Fecha de publicación del evento
    2007-12-22
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-04-16
  • Fuente del evento
    USFDA
  • 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
    Beckman Coulter, Brea, CA. (Hematology analyzer) - Product Code GKZ
  • Causa
    Patient mis-identification can occur: 1)- when a positive identifier (sample id or cassette/position) is manually edited to a positive identifier that is already in the to do list. the workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2)- when manually entering a patient id, if a blank space is entered between th.
  • Acción
    Product Corrective Action (PCA) letters were mailed on April 18,2007, to all GENS, LH500, LH750 and LH780 accounts. They are informed that a potential misidentification can occur in 2 scenarios. 1. When a positive identifier (Sample ID or CassetteIPosition) is manually edited to a positive identifier that is already in the ToDo list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2. When manually entering a Patient ID, if a blank space is entered between the characters in the Patient ID field, the system will only accept the characters before the space.----Short term fix----- The letter explains the issues and provides the customer work around. (Letters were sent by US mail). A customer response form was provided. The root cause of the problem is still under investigation, software upgrades, when approved will be made to devices.

Device

  • Modelo / Serial
    Part Number 178833. All software versions
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    World wide: USA and Canada
  • Descripción del producto
    COULTER LH 500 Series System, Part Number: 178833, Beckman Coulter, Brea, CA. (Hematology analyzer)
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA