BEUDAMED
    FDA Recall Terminated

    FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.

    Recall: Z-0032-2014 · Initiated August 20, 2013

    Recall

    Recall Number
    Z-0032-2014
    Event Number
    66293
    Firm
    Bio-Rad Laboratories
    FEI Number
    3008272466
    Product Code
    LOM
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    August 20, 2013
    Posted
    October 21, 2013
    Terminated
    November 13, 2013
    Address
    6565 185th Ave NE, Redmond, WA, 98052-5039

    Description

    FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.

    Reason

    The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.

    Action

    BioRad has sent an Urgent Product Correction letter dated August 19, 2013, to customers who had the EVOLIS FSE Upgrade Image Kit installed on the EVOLIS at their site by a Bio-Rad Laboratories Field Service Engineer (FSE). This issue impacts laboratory only if you are running the MONOLISA Anti-HBs EIA Quantitative Determination method with EVOLIS APF version 6.0 and TimeLiner Data Management Software. If you use this Quantitative Determination method with EVOLIS APF version 6.0, please contact Bio-Rad Laboratories for additional information or assistance. Bio-Rad Laboratories is currently developing and qualifying a software update CD consisting of the EVOLIS APF V6.0b and Timeliner Data Management Software to correct the issue. The software update CD will be installed by Bio-Rad Field Service Engineers at each of the customer sites when installing the EVOLIS APF V6.0b. Customers should contact Bio-Rad Laboratories at 1-800-224-6723, Option 2 and then Option 3 for any questions about this product correction.

    Distribution

    US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA

    Quantity

    23 kits