BEUDAMED
    FDA Enforcement Class II Ongoing

    Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique

    Recall: Z-0414-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0414-2026
    Event ID
    97497
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cepheid
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 5, 2025
    Initiation Date
    August 6, 2025
    Classification Date
    October 30, 2025
    Address
    904 E Caribbean Dr, N/A, Sunnyvale, CA, 94089-1189, United States

    Description

    Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique

    Reason

    As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

    Code Info

    Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Lot Numbers: 27815 27816 Batch Numbers: 1001424179 1001424181

    Distribution

    U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

    Quantity

    4,132 kits