BEUDAMED
    FDA Recall Terminated

    Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

    Recall: Z-0194-2013 · Initiated August 4, 2010

    Recall

    Recall Number
    Z-0194-2013
    Event Number
    63094
    Firm
    Clinical Diagnostic Solutions
    FEI Number
    3002684533
    Product Code
    JPK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 4, 2010
    Posted
    November 5, 2012
    Terminated
    August 14, 2014
    Address
    1800 Nw 65th Ave, Ste 2, Plantation, FL, 33313-4544

    Description

    Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

    Reason

    Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule

    Action

    Clinical Diagnostic Solutions, Inc. sent a "PRODUCT NOTIFICATION:BOULE CON DIFF TRI-LEVEL LOT 1005-549" letter dated August 4, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions regarding this notice, contact CDS Customer Service at 1-800-453-3328.

    Distribution

    Nationwide Distribution.

    Quantity

    690 packs