BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-0191-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0191-2013
    Event ID
    63096
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clinical Diagnostic Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2012
    Initiation Date
    March 24, 2011
    Classification Date
    November 2, 2012
    Termination Date
    August 13, 2014
    Address
    1800 Nw 65th Ave Ste 2, N/A, Plantation, FL, 33313-4544, United States

    Description

    Boule Con-Diff Hematology Control 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 Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai

    Code Info

    Product Part 502-012, Lot #1102-574

    Distribution

    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia

    Quantity

    197 vials