BEUDAMED
    FDA Recall Terminated

    Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252

    Recall: Z-0536-2007 · Initiated September 6, 2006

    Recall

    Recall Number
    Z-0536-2007
    Event Number
    36864
    Firm
    Diagnostic Chemicals, Ltd.
    FEI Number
    3002806809
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 6, 2006
    Posted
    February 27, 2007
    Terminated
    May 14, 2007
    Address
    16 McCarville Street, Charlottetown Canada Prince Edward Island

    Description

    Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252

    Reason

    Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct

    Action

    Diagnostic Chemicals Ltd, Canada notified customers by telephone and fax on 9/06/06 and advised to use the cap label to determine concentration of the calibrators. Accounts were asked to confirm and acknowledge receipt of the letter.

    Distribution

    Nationwide.

    Quantity

    38 kits