BEUDAMED
    FDA Recall Terminated

    Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,

    Recall: Z-1072-04 · Initiated June 11, 2004

    Recall

    Recall Number
    Z-1072-04
    Event Number
    29380
    Firm
    Gen Probe Inc
    FEI Number
    2024800
    Product Code
    NDZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 11, 2004
    Posted
    July 20, 2004
    Terminated
    September 9, 2004
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362

    Description

    Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,

    Reason

    Reduced stability

    Action

    Firm notified all customers by fax and/or overnight letter on June 11, 2004. The notice indicated that users can continue to the MTD product provided that teh Specimen Processing positive cell controls are used according to package insert instructions and valid assay results are obtained. The affected MTD Enzyme Reagent will be replaced with a new lot of reagent.