BEUDAMED
    FDA Enforcement Class II Terminated

    MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.

    Recall: Z-2225-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2225-2021
    Event ID
    87985
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioMerieux SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 18, 2021
    Initiation Date
    June 22, 2021
    Classification Date
    August 6, 2021
    Termination Date
    February 6, 2023
    Address
    Chemin De L'Orme, N/A, Marcy L'Etoile, N/A, N/A, France

    Description

    MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.

    Reason

    Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.

    Code Info

    MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.

    Distribution

    Distribution in the U.S. was nationwide. There was also military and government distribution.

    Quantity

    248 systems