BEUDAMED
    FDA Enforcement Class II Ongoing

    Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840

    Recall: Z-0836-2022 · Reported April 6, 2022

    Enforcement

    Recall Number
    Z-0836-2022
    Event ID
    89666
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Meridian Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 6, 2022
    Initiation Date
    February 15, 2022
    Classification Date
    March 30, 2022
    Address
    3471 River Hills Dr, N/A, Cincinnati, OH, 45244-3023, United States

    Description

    Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840

    Reason

    The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.

    Code Info

    UDI: 00840733102318 All units in the field, all serial numbers.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, PR, RI, SD, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Chile, Italy, Switzerland.

    Quantity

    452 units (398 US, 54 OUS)