ADVIA Centaur Herpes-2 IgG 10720849Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Herpes-2 IgG (HSV2) ADVIA Centaur - RGT – 100T · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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.
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.
Recalls naming this device
- Feb 8, 2021Class IITerminated
Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System.
Z-1274-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific devices
- biokitHSV-2 300028001Biokit, S.A. · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific1 recall0 reports
- IMMULITE® 2000 Systems Herpes I and II IgG 10381333Siemens Healthcare Diagnostics Products Ltd · Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific5 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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