BEUDAMED
    FDA Recall Terminated

    BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application.

    Recall: Z-2223-2009 · Initiated March 12, 2009

    Recall

    Recall Number
    Z-2223-2009
    Event Number
    52218
    Firm
    BioTek Instruments, Inc. Highland Park/Box
    FEI Number
    1217454
    Product Code
    JJQ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 12, 2009
    Posted
    September 18, 2009
    Terminated
    May 18, 2015
    Address
    998, Winooski, VT, 05404

    Description

    BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application.

    Reason

    Software design allowed false negatives to be read when wells are dark.

    Action

    BioTek Instruments, Inc. issued a "Product Recall Notification" dated March 13, 2009 information customers of the affected product. Follow-up letters with software installation instructions were sent March 25, 2009. For further information, contact BioTek Instruments, Inc. at 1-888-451-5171 extension 405.

    Distribution

    Worldwide Distribution -- United States (MN, CA, IL, MA, MI, CA, GA, FL, AZ and TX) and Peru.

    Quantity

    13