Events

Retiro De Equipo (Recall) de Device Recall BECKMAN COULTER iChemVELOCITY

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
    79575
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1643-2018
  • Fecha de inicio del evento
    2018-03-02
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162677
  • 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
    Automated urinalysis system - Product Code KQO
  • Causa
    Beckman coulter has determined that there is a potential for incorrect settings to be installed on north american ichemvelocity urine chemistry analyzers. 1. the installation of international settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations. 2. the installation of colors different from those stated in the instructions for use (colorless, straw, yellow, amber, red, blue) for output settings will result in incorrect reporting of colors. for example, if green is the color choice for the output setting instead of blue, green will be reported.
  • Acción
    Beckman Coulter sent an Urgent Field Safety Notice letter dated February 22, 2018 to the customers. The letter identified the affected product, problem and actions to be taken. Beckman Coulter will schedule a site visit to verify the reporting units of measurement for the laboratory within 90 days of this recall initiation. For questions call 800-854-3633.

Device

Device Recall BECKMAN COULTER iChemVELOCITY
  • Modelo / Serial
    All Fielded Serial Numbers with North American Configuration settings
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Malaysia, Singapore, Taiwan, Thailand, Turkey
  • Descripción del producto
    BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- || 7106, 800-3049, 800-3050, 800-3079, 800-3080, || 800-7190, 800-7713, 800-7714, 800-7715, 700- || 7176-001, 700-7177-001 || Product Usage: || The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterade, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. The measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver finction. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and 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