BEUDAMED
    FDA Recall Terminated

    ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany

    Recall: Z-1452-04 · Initiated August 19, 2004

    Recall

    Recall Number
    Z-1452-04
    Event Number
    29911
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    LIG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 19, 2004
    Posted
    September 14, 2004
    Terminated
    July 29, 2005
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany

    Reason

    Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decreases in patient sample values prior to current expiration of the reagents.

    Action

    Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, New Zealand and Japan were e-mailed copies of the recall letter on 8/19/04 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the potential for changes in the reagents over time that affect the shape of the calibration curve, producing controls out of range low and similar decreases in patient sample values. The accounts were instructed to manually update the expiration dates for the reagent lots according to the chart given in the recall letter for any of the affected lots remaining in inventory. The expiration date reported by the Architect instrument must also be manually updated.

    Distribution

    Canada, Germany, Singapore, Hong Kong, Australia, New Zealand and Japan.

    Quantity

    5754 kits