Events

Retiro De Equipo (Recall) de Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAM

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 Sysmex America, 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
    65214
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0949-2014
  • Fecha de inicio del evento
    2013-03-31
  • Fecha de publicación del evento
    2014-02-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118288
  • 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
    Counter, urine particle - Product Code LKM
  • Causa
    The current century break patch did not contain the same setting for the century break year for both the red hat linux and gui files. due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data retention setting in the application. this resulted in the database files meeting its maximum capacity and causing system p.
  • Acción
    A Product Notification letter dated July 2012, was sent to Siemens Healthcare Diagnostics. The letter suggested that an attached procedure should be followed for an server that requires the Century Break parameter change. If Siemens Healthcare Diagnostics has any questions about the procedure, the firm's representatives can contact the Sysmex Technical Assistance Center at 1-888-879-7639. A response form was also included with the letter requesting the Siemens Healthcare Diagnostics complete and return it. A second Product Notification letter dated September 2012, was sent to Siemens Healthcare Diagnostics. The letter contained largely the same instructions as the July 2012, letter. A third Product Notification letter dated March 2013, was sent to Siemens Healthcare Diagnostics. The letter include substantially similar instructions as the pervious letters; however, the procedure for changing the Century Break parameter was expanded.

Device

Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAM
  • Modelo / Serial
    Software versions 1.0, 1.01, 1.1.1, 1.1.2
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IS, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and WI and the country of Canada.
  • Descripción del producto
    The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.
  • Manufacturer
    Sysmex America, Inc.

Manufacturer

Sysmex America, Inc.
  • Dirección del fabricante
    Sysmex America, Inc., 1 Nelson C White Pkwy, Mundelein IL 60060-9528
  • Empresa matriz del fabricante (2017)
    Sysmex Corp.
  • Source
    USFDA