Events

Retiro De Equipo (Recall) de Device Recall Beckman Coulter, AU5800 Chemistry Analyzer

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
    74568
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2310-2016
  • Fecha de inicio del evento
    2015-07-30
  • Fecha de publicación del evento
    2016-08-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147927
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Beckman coulter has received complaints regarding leaking and cracked c cups. when the cup cracks, coolant can leak onto the connectors of the printed circuit boards (pcb) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.
  • Acción
    In March 2011, the material and molding process of the Coolant cup (C cup) was changed. BEC did not issue a customer notification letter, as we do not believe that a notificationletter was either warranted or of any potential use or value to our customers, because the coolant cup (C cup) is an internal component that only a BEC Field Service Engineer (FSE) can access and inspect  i.e., the C cup is not in a customer-accessible part of the analyzer. Thus, there are no specific actions the customer could take to inspect, identify, or mitigate the potential for a crack or leakage of the C cup. For questions regarding this recall call 714-961-4933.

Device

Device Recall Beckman Coulter, AU5800 Chemistry Analyzer
  • Modelo / Serial
    1040016
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide (including Guam and Puerto Rico), and Internationally to Albania, Algeria, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Liberia, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States Uruguay, Viet Nam, Zambia, Zimbabwe.
  • Descripción del producto
    AU5800 Chemistry Analyzers, Reference No. A98352 || The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.
  • 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