BEUDAMED
    FDA Enforcement Class II Ongoing

    FlexLab (FLX); Version: FLX-217-40;

    Recall: Z-0596-2026 · Reported December 3, 2025

    Enforcement

    Recall Number
    Z-0596-2026
    Event ID
    97887
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Inpeco S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 3, 2025
    Initiation Date
    October 30, 2025
    Classification Date
    November 25, 2025
    Address
    Via San Gottardo 10, N/A, Lugano, N/A, N/A, Switzerland

    Description

    FlexLab (FLX); Version: FLX-217-40;

    Reason

    The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes

    Code Info

    UDI-DI: 07640172344002; Serial number: FXX.0004, FXX.0006, FXX.0009, FXX.0022, FXX.0023, FXX.0024, FXX.0027, FXX.0028, FXX.0034, FXX.0036, FXX.0041, FXX.0042, FXX.0043, FXX.0046;

    Distribution

    US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.

    Quantity

    14 units (1 US, 13 OUS)