BEUDAMED
    FDA Recall Terminated

    RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. 20 vials Whole Blood - 2.0mL; dried 20 vials Diluent - 4.0 mL The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes.

    Recall: Z-2110-2010 · Initiated June 24, 2010

    Recall

    Recall Number
    Z-2110-2010
    Event Number
    56114
    Firm
    International Technidyne Corp.
    FEI Number
    1000526865
    Product Code
    KFF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 24, 2010
    Posted
    July 28, 2010
    Terminated
    September 23, 2010
    Address
    6-8 Olsen Avenue, Edison, NJ, 08820-2419

    Description

    RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. 20 vials Whole Blood - 2.0mL; dried 20 vials Diluent - 4.0 mL The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes.

    Reason

    An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may become less potent over time and result in excessive High LQC Failures.

    Action

    ITC sent "URGENT MEDICAL DEVICE RECALL" letters dated June 24, 2010, via Federal Express to Laboratory Director, Clinical Laboratory Manager, or Point of Care Coordinator consignees/customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to check their inventory for the product, if they have boxes or loose vials to please stop using the product, remove it from inventory and contact ITC Technical Support to arrange return. They were also instructed to complete the attached Customer Account Tracking Form, whether or not they have remaining inventory, and return it by fax, email or mail. If you have any questions, please call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (international), Extension 4707 or email [email protected].

    Distribution

    Worldwide distribution: USA including states of CA, NC, TX, FL, MD, OK, NY, and NJ and country of Italy.

    Quantity

    38 in US, 3 Out of US