BEUDAMED
    FDA Recall Terminated

    IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-0230-04 · Initiated November 13, 2003

    Recall

    Recall Number
    Z-0230-04
    Event Number
    27717
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    MLM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 13, 2003
    Posted
    December 17, 2003
    Terminated
    October 29, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

    Reason

    Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances.

    Action

    Device correction recall initiated by letters dated 11/12/03. Letters were sent to all current IMx Tacrolimus II customers worldwide, advising them that calibration errors and controls out of range be the result of variance with the sample pretreatment steps listed in the package insert, and that the protein interference data in the insert is not representative of assay performance (12% when it should state less than 22% error) . A Customer Training Guide was included in the letter, outlining steps to aid the assay user in performing the pretreatment step and listing the most common deviations that can impact results.

    Distribution

    Nationwide and internationally to Guatemala, Venezuela, Columbia, Peru, Chile, Australia, Panama, Argentina, Puerto Rico, Dominican Republic, Canada, Germany, New Zealand, England, Japan, Singapore, Thailand, Korea and Costa Rica.

    Quantity

    not lot specific