BEUDAMED
    FDA Recall 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 · Initiated April 22, 2014

    Recall

    Recall Number
    Z-1941-2014
    Event Number
    68396
    Firm
    Meridian Bioscience Inc
    FEI Number
    1524213
    Product Code
    OMN
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 22, 2014
    Posted
    June 27, 2014
    Terminated
    June 30, 2014
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244-3023

    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.

    Action

    Meridian sent an Urgent Medical Device Recall letter dated April 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return their unit to Meridian Bioscience. Meridian's Technical Support Staff will call them directly to provide them with a return authorization number and instructions for decontaminating, packaging and shipping the unit. For additional information customers were instructed to call 800-343-3858 (North America or 513-271-3700 (Worldwide).

    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