BEUDAMED
    FDA Recall Terminated

    Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892

    Recall: Z-0361-2007 · Initiated December 5, 2006

    Recall

    Recall Number
    Z-0361-2007
    Event Number
    37011
    Firm
    Diagnostic Chemicals, Ltd.
    FEI Number
    3002806809
    Product Code
    DKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 5, 2006
    Posted
    January 23, 2007
    Terminated
    January 27, 2016
    Address
    16 McCarville Street, Charlottetown Canada Prince Edward Island

    Description

    Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892

    Reason

    Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories

    Action

    For product shipped by DCL to one customer notification letter dated 12/5/06 sent out to customer to return/discard product. Replacement will be sent to customer. For product shipped to DCL (USA) warehouse notification sent to discard kits remaining in stock. For product remaining at DCL Canada in-house notification sent out to discard in-house kits.

    Distribution

    PA

    Quantity

    55 kits shipped to one customer