BEUDAMED
    FDA Recall Terminated

    ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA

    Recall: Z-1204-06 · Initiated June 6, 2006

    Recall

    Recall Number
    Z-1204-06
    Event Number
    35612
    Firm
    Abbott Laboratories MPG
    FEI Number
    1415939
    Product Code
    DBF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 6, 2006
    Posted
    July 4, 2006
    Terminated
    January 18, 2008
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064 USA

    Reason

    Some ARCHITECT Ferritin Reagent lots may not be meeting the accuracy by correlation to AxSYM claims as they are listed in the package insert (slope of 1.0 +/- 0.2).

    Action

    Abbott international affiliates were e-mailed copies of the recall letter on 6/6/06 for translation where needed and dissemination to their accounts receiving the affected product. The end users were advised that a shift in patient and/or control results occurs when changing to reagent and calibrator lots manufactured using the new internal reference standard, and that the accuracy by correlation between Architect and AxSYM Ferritin reagent lots does not match those stated in the package insert. The accounts advised to set new targets for their controls or use the enclosed targets in Attachment A when they change to the assay materials manufactured using the new internal reference standards. The accounts were requested to keep a copy of the letter on file until the revised package insert is received.

    Distribution

    Canada, Germany, Uruguay, Japan, Singapore, Hong Kong, South Korea, Australia and New Zealand

    Quantity

    10,725 kits