BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0724-2026 · Initiated November 5, 2025

    Recall

    Recall Number
    Z-0724-2026
    Event Number
    97911
    Firm
    Cepheid
    FEI Number
    3004530258
    Product Code
    PEU
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 5, 2025
    Posted
    November 26, 2025
    Address
    904 E Caribbean Dr, Sunnyvale, CA, 94089-1189

    Description

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

    Reason

    Product testing did not meet expected stability criteria.

    Action

    Cephid notified consignees on about 11/05/2025 via FedEx letter. Consignees were instructed to ensure no affected units remain in inventory or are available for use since the affected lots have passed their expiration date. Past results obtained from Xpert MTB/RIF batch 1000812229 lot 41302 may be inaccurate. If these results were used to make clinical management decisions, it is recommended that the results be reviewed in the context of corresponding culture data, drug susceptibility testing, clinical presentation and other relevant laboratory information to ensure accurate patient care. If there is uncertainty or insufficient information to confirm the result, repeat testing to ensure accuracy. Consignees were requested to notify relevant clinical teams as needed. Cepheid will provide products for the purposes of retesting. Kits are expected to ship within 5 business days following receipt of the completed response form. Additionally, consignees were instructed to complete and return the Customer Response Form.

    Distribution

    US Nationwide distribution and Puerto Rico.

    Quantity

    9,880 units