BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0619-2013 · Initiated November 7, 2012

    Recall

    Recall Number
    Z-0619-2013
    Event Number
    63825
    Firm
    HemoCue AB Kuvettgaten 1 Angelholm Sweden
    FEI Number
    3003044483
    Product Code
    JIQ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 7, 2012
    Posted
    December 28, 2012
    Terminated
    March 14, 2013

    Description

    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.

    Reason

    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.

    Action

    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.

    Distribution

    Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.

    Quantity

    48 affected analyzers