BEUDAMED
    FDA Recall Terminated

    DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine.

    Recall: Z-2326-2009 · Initiated February 12, 2009

    Recall

    Recall Number
    Z-2326-2009
    Event Number
    51156
    Firm
    Diagnostic Chemicals, Ltd.
    FEI Number
    3002806809
    Product Code
    JFY
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    February 12, 2009
    Posted
    September 30, 2009
    Terminated
    May 23, 2012
    Address
    16 McCarville Street, Charlottetown Canada Prince Edward Island

    Description

    DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine.

    Reason

    Labeled with extended expiration date (24 months instead of 18 months)

    Action

    Genzyme Corp. notified consignees by Letter dated February 12, 2009 via Federal Express. Accounts are requested to discontinue use and discard units. Customers were also asked to complete and sign the Confirmation of Notification the fax to 1-902-628-6504. For further information, contact Genzyme Technical Support at 1-800-565-0265.

    Distribution

    Worldwide Distribution -- United States (AL, CA, NJ, MO, PA, KY, FL, LA, MN, NY, NC, OH, TX and UT), Canada and Korea.

    Quantity

    82 kits