BEUDAMED
    FDA Recall Terminated

    Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).

    Recall: Z-0935-04 · Initiated June 11, 2003

    Recall

    Recall Number
    Z-0935-04
    Event Number
    28909
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    KLT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 11, 2003
    Posted
    July 20, 2004
    Terminated
    May 10, 2004
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).

    Reason

    Product was found to produce higher recoveries by about 7-12% compared to other lots.

    Action

    Users were requested to discard and ask for replacement of the lot in question by letter.

    Distribution

    Nationwide and Canada

    Quantity

    unknown