BEUDAMED
    FDA Recall Terminated

    HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility and is not intended for home use.

    Recall: Z-1854-2011 · Initiated January 21, 2011

    Recall

    Recall Number
    Z-1854-2011
    Event Number
    57773
    Firm
    ITC-Nexus Dx, Inc.
    FEI Number
    1000526865
    Product Code
    GKR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 21, 2011
    Posted
    March 31, 2011
    Terminated
    November 2, 2012
    Address
    6-8 Olsen Ave, Edison, NJ, 08820-2419

    Description

    HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility and is not intended for home use.

    Reason

    ITC has determined that results obtained using certain lots of Hgb Pro Professional Hemoglobin Test Strips may differ from results obtained using a reference hemoglobin testing system.

    Action

    ITC-Nexus Dx, Inc. sent an Urgent Medical Device Recall letter with return response forms to end users and distributors dated January 21, 2011 via UPS overnight. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory to determine if they had an of the affected lots. If they have full boxes or loose containers of the affected lots customers were instructed to stop using the product and remove it from inventory. Customers were requested to fill out the return response form and send it back to ITC via fax, email or mail. For questions customers were instructed to call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (International)), Extension 4707 or e-mail [email protected].

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of India, Oman, South Africa, and Singapore

    Quantity

    2500 containers + 50,563 addtnl containers =53063 containers