Events

Retiro De Equipo (Recall) de Device Recall HemoCue Albumin 201 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 HemoCue AB.

¿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
    63825
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0619-2013
  • Fecha de inicio del evento
    2012-11-07
  • Fecha de publicación del evento
    2012-12-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114839
  • 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
    Turbidimetric method, protein or albumin (urinary, non-quant.) - Product Code JIQ
  • Causa
    Incorrect version of quick reference guide (qrg) was delivered with products in shipment made from april1 st 2011 and onwards. in addition, a warranty statement was missing in the analyzer package.
  • Acción
    HemoCue sent an "IMPORTANT MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Correction Notification Verification Form was included for customers to complete and return. Contact the firm at 562-668-5741 for questions regarding this notification.

Device

Device Recall HemoCue Albumin 201 Analyzer
  • Modelo / Serial
    See serial numbers of affected devices in attachment profided by firm.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
  • Descripción del producto
    Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. || The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.
  • Manufacturer
    HemoCue AB

Manufacturer

HemoCue AB
  • Dirección del fabricante
    HemoCue AB, Kuvettgaten 1, Angelholm Sweden
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA