BEUDAMED
    FDA Enforcement Class II Ongoing

    Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

    Recall: Z-0724-2026 · Reported December 3, 2025

    Enforcement

    Recall Number
    Z-0724-2026
    Event ID
    97911
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cepheid
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2025
    Initiation Date
    November 5, 2025
    Classification Date
    November 26, 2025
    Address
    904 E Caribbean Dr, N/A, Sunnyvale, CA, 94089-1189, United States

    Description

    Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

    Reason

    Product testing did not meet expected stability criteria.

    Code Info

    Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02

    Distribution

    US Nationwide distribution and Puerto Rico.

    Quantity

    9,880 units