BEUDAMED
    FDA Enforcement Class II Terminated

    illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.

    Recall: Z-1941-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1941-2014
    Event ID
    68396
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Meridian Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 9, 2014
    Initiation Date
    April 22, 2014
    Classification Date
    June 27, 2014
    Termination Date
    June 30, 2014
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244-3023, United States

    Description

    illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.

    Reason

    Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.

    Code Info

    Serial Numbers: IP2669, IP2670, IP2671, IP2672, IP2673, IP2674, IP2675, IP2676, IP2677, IP2678, IP2680, IP2682, IP2683, IP2684, IP2685, IP2686, IP2687, IP2688, IP2689, IP2690, IP2691, IP2692, IP2693, IP2694, IP2695, IP2696, IP2697, IP2698, IP2699, IP2700, IP2701, IP2702, IP2703, IP2704, IP2705, IP2706.

    Distribution

    Worldwide Distribution - USA including AL, AZ, CA, CO, FL, IA, IN, LA, MA, ME, MI, MN, NJ, NY, OH, PA, and WV. Internationally to Australia.

    Quantity

    35 instruments