Events

Retiro De Equipo (Recall) de Synchron LXi 725

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
    58567
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2132-2011
  • Fecha de inicio del evento
    2011-04-05
  • Fecha de publicación del evento
    2011-05-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99602
  • 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
    Discrete Photometric Chemistry Analyzer for Clinical Use - Product Code JJE
  • Causa
    The recall was initiated because beckman coulter has received reports of incorrect electrolyte results on synchron lx systems due to a variety of maintenance-related hardware issues.
  • Acción
    The recall communication was initiated on 04/05/2011 with Beckman Coulter forwarding a Product Correction letter with attached customer response form to the affected customers via US Postal Service. The letter informed customers of the products affected, the issue, the impact, and the actions to be taken. Customers were instructed to follow the steps provided in order to address the issues related to microbial contamination; and to complete and return the enclosed response form within 10 days so that receipt of this important information could be confirmed. In addition, the letter requested customers share the information with their laboratory staff and retain the notification as part of your laboratory Quality System documentation. For customers who have any questions regarding this update, the letter indicated to contact Customer Support Center Call Center via the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support/. They may also contact Beckman Coulter at (800) 854-3633 in the United States and Canada or through your local Beckman Coulter representative. Beckman Coulter will issue two additional recall notification ("UPDATE TO URGENT PRODUCT CORRECTION Synchron LX20, LX20 PRO, LXi 725 Clinical Systems") beginning on 05/20/2011, one to Laboratory Directors and one to Physicians. The notices will be mailed via US Postal Service on Friday, May 20th. Customers who have subscribed to email notifications will receive an email containing the letters on Monday, May 23th. Both letter informs the Laboratory Directors and Physicians that Beckman Coulter has received reports of erroneous/aberrant sodium, potassium, chloride and calcium results that have been released from the laboratory. Electrolyte shifts can be low or high and may occur above, below or within the normal range. Laboratory Directors were instructed to immediately disseminate the Attachment to this letter (via notification/alert procedure appropriate to your

Device

Synchron LXi 725
  • Modelo / Serial
    All Serial Numbers.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- Australia, Belgium, Canada, China, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Hong Kong, India, Ireland, Italy, Japan, Republic of Korea, Kuwait, Mexico, Netherlands, Oman, Panama, Philippines, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and the United States.
  • Descripción del producto
    Synchron LXi 725, Part Number: 476501. || Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
  • 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