Alethia™ Group B Streptococcus 480350Recalls & reported problems
Meridian Bioscience, Inc. · The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, 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 Alethia 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 Alethia 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. The Alethia GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Alethia Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Recalls naming this device
- Oct 7, 2025Open, Classified
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Z-0569-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test devices
- 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
- 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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