Events

Retiro De Equipo (Recall) de Synchron LX20 PRO Clinical Chemistry 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
    45960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1095-2008
  • Fecha de inicio del evento
    2007-04-05
  • Fecha de publicación del evento
    2008-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66582
  • 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
    Chemistry Analyzer (Discrete Photometric) - Product Code JJE
  • Causa
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • Acción
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.

Device

Synchron LX20 PRO Clinical Chemistry System
  • Modelo / Serial
    Part Number: 476100. All serial numbers. All software versions.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Canada.
  • Descripción del producto
    Synchron LX20 PRO, Part Number 476100, Beckman Coulter, Inc.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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