Xpert MRSA NxG GXMRSA-NXG-10Recalls & reported problems
Cepheid · Xpert MRSA NxG kit; 10 test kit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07332940001711), received between Mar 13, 2025 and Mar 13, 2025 — classified as 1 death.
The most frequently reported specific device problem is “False Negative Result” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
Patient problems
- Cardiac Arrest1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 13, 2025False Negative Result; False Negative Result
US CUSTOMER CONTACTED CEPHEID TO DISCUSS DISCREPANT RESULTS FOR ONE PATIENT USING MRSA NXG FOR THE MRSA ANALYTE. ON (B)(6) 2025, PATIENT WAS ADMITTED IN A STATE OF SHOCK. ON THE SAME DAY, A NASAL SWAB (SAMPLE 1) WAS COLLECTED ON LABEL USING THE COPAN ESWAB COLLECTION DEVICE AND PROCESSED PER THE IFU. SAMPLE WAS RUN ON (B)(6) 2025 ON XPERT MRSA NXG RESULTED IN MRSA NOT DETECTED. THIS RESULT WAS REPORTED TO THE PHYSICIAN. A SEPARATE BLOOD CULTURE SAMPLE (SAMPLE 2) WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025. THE DIRECT BLOOD SAMPLE WAS PLATED AND THE ISOLATE GROWN WAS IDENTIFIED AS MRSA. THIS RESULT PROMPTED THE CUSTOMER TO PLATE THE NASAL ESWAB SAMPLE 1 ON BAP, CHOC, AND MACCONKEY PLATES. AN ORGANISM GREW AND WAS ISOLATED AND IT WAS IDENTIFIED AS MRSA BY VITEK 2 SUSCEPTIBILITY TESTING, WHICH SHOWED AMOXICILLIN, AMPICILLIN, OXACILLIN, CEFAZOLIN, CIPROFLOXACIN, AND LEVOFLOXACIN RESISTANCE. THE CUSTOMER REPORTED PBP2A TESTING WAS ALSO PERFORMED ON SPECIMEN WHICH RESULTED AS POSITIVE. DATE OF RESULTS UNKNOWN. ON (B)(6) 2025, SAMPLE 2 WAS RAN ON BIOFIRE BCID WHICH RESULTED IN S. AUREUS, NEGATIVE FOR MRSA. THE PATIENT RECEIVED A SINGLE DOSE OF VANCOMYCIN ON (B)(6) 2025. IT WAS STOPPED A
Patient problems: Cardiac Arrest; Insufficient Information
MAUDE report 21599431 ↗
Other System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen devices
- BD MAX™ MRSA XT 443461Becton, Dickinson And Company · SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN1 recall9 reports
- Gram-Positive Blood Culture (BC-GP) Utility Tray 20-011-018Nanosphere, Inc. · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen1 recall0 reports
- Gram-Positive Blood Culture (BC-GP) Utility Tray 20-011-018Luminex Corporation · SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN1 recall0 reports
- BD MAX™ MRSA 442953Geneohm Sciences Canada Inc · SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN1 recall0 reports
- Xpert SA Nasal Complete GXSACOMP-10Cepheid · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen1 recall0 reports
- Xpert MRSA/SA Blood Culture GXMRSA/SA-BC-10Cepheid · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen2 deaths6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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