Xpert GBS GXGBS-100N-10Recalls & reported problems
Cepheid · Xpert GBS kit; 10 test kit · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07332940000127), received between Apr 9, 2024 and Apr 9, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “False Negative Result” (1 report).
1 other recall cover devices cleared under the same FDA submission (K060540); they may or may not involve this specific model.
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
- Sepsis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2024False Negative Result; False Negative Result
UK CUSTOMER CONTACTED CEPHEID ON 12-MAR-2024 TO REPORT A QUESTIONABLE NEGATIVE RESULT ON XPERT GBS ASSAY. ON (B)(6) 2024 PATIENT MOTHER VAGINAL/RECTAL SWAB WAS COLLECTED AND TESTED ON XPERT GBS PER PI AT 11:25 PM. ON (B)(6) 2024 AT 12:21 AM, THE TEST RESULT REPORTED: NEGATIVE. ON (B)(6) 2024 AFTER CHILDBIRTH, THE BABY EXHIBITED SYMPTOMS AND WAS SAID TO BE UNWELL. A BLOOD SAMPLE WAS COLLECTED FROM THE BABY FOR BLOOD CULTURE ANALYSIS AND SENT TO ANOTHER LAB (SPECIFIC TEST PERFORMED AND DATE OF TEST NOT SPECIFIED). THE PRESENCE OF GBS WAS CONFIRMED IN THE BLOOD CULTURE. DIAGNOSIS PROVIDED BY MEDICAL PRACTITIONERS FOR BOTH PATIENTS WAS POSITIVE FOR GBS. BOTH WERE TREATED WITH ANTIBIOTICS AND BOTH PATIENTS ARE NOW IN STABLE CONDITION. A REQUEST WAS SENT TO THE ADDITIONAL LAB FOR THE BLOOD CULTURE TO PERFORM FURTHER ANALYSIS.
Patient problems: Sepsis
MAUDE report 19076025 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K060540. One submission often covers many models, so check the product and lot details in each record.
- Z-0376-2008 · Sep 5, 2007 · TerminatedCepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089
Other Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test devices
- Alethia™ Group B Streptococcus 480350Meridian Bioscience, Inc. · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test1 recall0 reports
- BD MAX™ GBS 441772Becton, Dickinson And Company · Nucleic acid amplification assay system, group b streptococcus, direct specimen test38 reports
- Xpert GBS LB GXGBS-LB-10Cepheid · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test2 reports
- illumigene Group B Streptococcus 280350Meridian Bioscience, Inc. · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test1 report
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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