BEUDAMED
    FDA Recall Terminated

    Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation.

    Recall: Z-0516-2009 · Initiated June 1, 2007

    Recall

    Recall Number
    Z-0516-2009
    Event Number
    48190
    Firm
    Quantimetrix Corporation
    FEI Number
    2020715
    Product Code
    JPK
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 1, 2007
    Posted
    January 17, 2009
    Terminated
    February 18, 2009
    Address
    2005 Manhattan Beach Blvd, Redondo Beach, CA, 90278-1205

    Description

    Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation.

    Reason

    This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.

    Action

    The recall communication was initiated when customer both direct and distributors who have purchased the lots were mailed a recall notification letter dated June 8, 2008 with instructions which was sent via first class mail. Customers were requested to assist in the voluntary recall of the listed product and if any of the affected lots have been consumed please review their records to ensure that the obtained values conform to the stated specifications found in the lot specific product insert.

    Distribution

    Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY.

    Quantity

    24,937 sets for all products.