BEUDAMED
    FDA Recall Terminated

    ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.

    Recall: Z-1576-05 · Initiated March 9, 2004

    Recall

    Recall Number
    Z-1576-05
    Event Number
    32608
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MZO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 9, 2004
    Posted
    October 1, 2005
    Terminated
    July 22, 2006
    Address
    1951 Northwestern Ave S, Stillwater, MN, 55082-7536

    Description

    ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.

    Reason

    An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.

    Action

    Dear Customer letters, dated 03/08/2004 were sent to customers informing them of the specification error and instructing users to validate their assays manually.

    Distribution

    AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI & WV

    Quantity

    128