illumigene Group B Streptococcus 280350Recalls & reported problems
Meridian Bioscience, Inc. · The illumigene Group B Streptococcus (GBS) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth. The illumigene GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the illumigene GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections. · 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 00840733101342), received between Oct 9, 2017 and Oct 9, 2017 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
- Fever1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A (B)(6) OLD BABY CAME TO ((B)(6) HOSPITAL) ED WITH FEVER. SPINAL TAP AND BLOOD CULTURES WERE DRAWN. CSF AND BLOOD CULTURE WERE POSITIVE FOR GROUP B STREP. BABY WAS TRANSFERRED TO (B)(6) NEONATAL ICU AND WAS ON VENTILATOR.
Patient problems: Bacterial Infection; Fever
MAUDE report 6933518 ↗
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
- Xpert GBS GXGBS-100N-10Cepheid · 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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