BEUDAMED
    FDA Recall Terminated

    NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237***

    Recall: Z-1071-2007 · Initiated March 30, 2007

    Recall

    Recall Number
    Z-1071-2007
    Event Number
    37921
    Firm
    Wako Chemicals USA, Inc.
    FEI Number
    3005625991
    Product Code
    JIT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 30, 2007
    Posted
    July 12, 2007
    Terminated
    July 24, 2007
    Address
    1600 Bellwood Rd, Richmond, VA, 23237-1326

    Description

    NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237***

    Reason

    Diagnostic reagent for clinical laboratory testing was incorrectly labeled.

    Action

    The recalling firm notified consignees by letter 03/30/07 and advised of labeling error. Consignees were advised that they could return the product for relabeling or affix correct label enclosed with the notification. Distributors were requested to forward notification to end users. The firm subsequently notified consignees on 04/26/07 by fax that product should be returned for label correction.

    Distribution

    Worldwide, including USA, Germany and Canada.

    Quantity

    94 cartons