BEUDAMED
    FDA Recall Terminated

    Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

    Recall: Z-1436-2014 · Initiated February 24, 2013

    Recall

    Recall Number
    Z-1436-2014
    Event Number
    67724
    Firm
    Clinical Diagnostic Solutions
    FEI Number
    3002684533
    Product Code
    JPK
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 24, 2013
    Posted
    April 9, 2014
    Terminated
    August 7, 2014
    Address
    1800 Nw 65th Ave, Ste 2, Plantation, FL, 33313-4544

    Description

    Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

    Reason

    Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.

    Action

    Clinical Diagnostic Solutions sent a Notification letter dated February 26, 2014 to affected customers. The letter identified the affected product, problem and the actions to be taken. For questions contact Technical Support at 1-800-453-3328.

    Distribution

    Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.

    Quantity

    3,540