BEUDAMED
    FDA Enforcement Class II Ongoing

    MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

    Recall: Z-1024-2026 · Reported January 21, 2026

    Enforcement

    Recall Number
    Z-1024-2026
    Event ID
    98260
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    REPLIGEN CORPORATION
    Voluntary / Mandated
    FDA Mandated
    Report Date
    January 21, 2026
    Initiation Date
    December 10, 2025
    Classification Date
    January 13, 2026
    Address
    111 Locke Dr, Marlborough, MA, 01752-7236, United States

    Description

    MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

    Reason

    Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle.

    Code Info

    PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496

    Distribution

    U.S.

    Quantity

    33