BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated February 15, 2022

    Recall

    Recall Number
    Z-0836-2022
    Event Number
    89666
    Firm
    Meridian Bioscience Inc
    FEI Number
    1524213
    Product Code
    OOI
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    February 15, 2022
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244-3023

    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.

    Action

    A Letter dated 02/15/2022 sent via FedEx notified users of the risk of false-positives and provided instructions on how to recognize a compromised photomultiplier tube via error codes and based on various combinations of positive and indeterminate results. If a positive result with the negative control is obtained or false positive suspected, users are to contact Technical Service and cease using the instrument. The company is developing software solution aimed at identifying photomultiplier tubes that are at risk for failure and is seeking a hardware fix to this issue.

    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)