BEUDAMED
    FDA Recall Terminated

    Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250

    Recall: Z-0404-03 · Initiated November 7, 2002

    Recall

    Recall Number
    Z-0404-03
    Event Number
    25081
    Firm
    Elan Diagnostics, Inc.
    FEI Number
    1221157
    Product Code
    CHH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2002
    Posted
    December 31, 2002
    Terminated
    May 15, 2012
    Address
    2 Thurber Boulevard, Smithfield, RI, 02917

    Description

    Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250

    Reason

    Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery

    Action

    The firm notified Distributors by telephone on 11/4/02 and end-users by Certified Mail on 11/4/02. Distributors and End-users are requested to dispose of product and return label for replacement product.

    Distribution

    Nationwide

    Quantity

    170 Kits