Events

Retiro De Equipo (Recall) de Device Recall AU5800 Clinical 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
    65440
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1834-2013
  • Fecha de inicio del evento
    2013-06-03
  • Fecha de publicación del evento
    2013-07-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118910
  • 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
    The recall was initiated because beckman coulter has identified a software error on au5800 analyzers with the automation ready (ar) sampler kit. this software error results in the failure of the concentrated wash solution pump to stop, creating an overflow or leak on each analyzer unit.
  • Acción
    An Urgent Product Correction letter dated 5/29/13 was sent on the week of June 3, 2013 to all the customers who received the AU5800 Clinical Chemistry Analyzer with Automation Ready (AR) Connection (All Software versions). The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to complete and return the enclosed Response Form within 10 days and to share the information with their laboratory staff. Customers with questions are instructed to contact the 24 hours Call Center (Hotline) at (800) 854-3633 in the US and Canada.

Device

Device Recall AU5800 Clinical Chemistry Analyzer
  • Modelo / Serial
    Model Numbers: AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU5821-03, AU5831-03, AU5841-03, AU5811-04, AU5821-04, AU5831-04, AU5841-04, AU5811-06, AU5821-06, AU5831-06, AU5841-06  Part Numbers: A94906, A94911, A94916, A91921 A94907, A94912, A94917, A94922 A94908, A94913, A94918, A94923 A94909, A94914, A91949, A94924 A94910, A94915, A94920, A94925  Serial Numbers: All
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution, including Nationwide (US) and the countries of China, Italy, Japan, Canada, Turkey, United Kingdom, Singapore, Israel, and the Netherlands.
  • Descripción del producto
    AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
  • 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