BEUDAMED
    FDA Enforcement Class III 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 · Reported October 30, 2013

    Enforcement

    Recall Number
    Z-0032-2014
    Event ID
    66293
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2013
    Initiation Date
    August 20, 2013
    Classification Date
    October 21, 2013
    Termination Date
    November 13, 2013
    Address
    6565 185th Ave NE, N/A, Redmond, WA, 98052-5039, United States

    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.

    Code Info

    Lot 122822

    Distribution

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

    Quantity

    23 kits