BEUDAMED
    FDA Recall Open, Classified

    Revogene, Catalog no. 610210. IVD test instrument

    Recall: Z-1479-2022 · Initiated June 22, 2022

    Recall

    Recall Number
    Z-1479-2022
    Event Number
    90549
    Firm
    Meridian Bioscience Inc
    FEI Number
    1524213
    Product Code
    OOI
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 22, 2022
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244-3023

    Description

    Revogene, Catalog no. 610210. IVD test instrument

    Reason

    When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.

    Action

    On June 22, 2022, the firm notified customers via email. Customers were instructed that if a run is aborted and an error code presented, they SHOULD NOT open the instrument. DO NOT touch the retention ring or the inside of the lid as they may be hot. The firm recommends that customers wait approximately 10 minutes to allow the instrument to cool prior to opening the lid and removing the test devices. The firm has developed a firmware solution to prevent the lid from being opened after an aborted run prior to the completion of the cooling period. The Meridian Bioscience Technical Services team will contact you to set up an appointment for firmware installation once available.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland.

    Quantity

    459 (394 US, 65 OUS)