ADVIA Centaur® Systems HBsAg QC 10309059Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · HBsAg (HBs) Quality Control Material Kit · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414472881), received between Dec 22, 2021 and Dec 22, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2021Leak/Splash; Leak/Splash
THE CUSTOMER CONTACTED A CUSTOMER CARE CENTER AND REPORTED THAT WHILE DISCARDING UNCAPPED ALIQUOTS OF SIEMENS ADVIA CENTAUR (B)(6) QUALITY CONTROL MATERIAL THE OPERATOR WAS SPLASHED IN THE EYE. THE OPERATOR WAS WEARING PRESCRIPTION EYEGLASSES, NOT LABORATORY SAFETY GLASSES AND THE LIQUID SPLASHED UNDER HER GLASSES. THE OPERATOR RINSED HER EYE WITH AN EYE WASH. THERE WAS NO PAIN, REDNESS OR APPARENT INJURY TO THE EYE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13060964 ↗
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- VITROS 6801926Ortho Clinical Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)1 recall0 reports
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- ADVIA Centaur® HBsII 10492138Siemens Healthcare Diagnostics Inc. · Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)18 reports
- Atellica™ IM HBsII 10995604Siemens Healthcare Diagnostics Inc. · Test, hepatitis b (b core, be antigen, be antibody, b core igm)12 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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