Elecsys Anti-HBs 11820524160Recalls & reported problems
Roche Diagnostics GmbH · 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 07613336159781), received between Aug 5, 2025 and Aug 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (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.
Reports received per month
Most reported problems
Device problems
- High Test Results1
- Non Reproducible Results1
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.
MalfunctionAug 5, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-HBS RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS E 602 MODULE. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: THE INITIAL RESULT WAS 9.58 IU/L (INDETERMINATE). THE FIRST REPEAT RESULT WAS 3.50 IU/ML WITH A DATA FLAG (NEGATIVE). THE SECOND REPEAT RESULT WAS 32.29 WITH A DATA FLAG IU/ML (POSITIVE). THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY, AS PATIENT SAMPLES WITH "INDETERMINATE" INITIAL RESULTS ARE RERUN TWICE. THE RESULT WAS REPORTED AS "NEGATIVE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22715427 ↗
Other Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) devices
- Elecsys HBsAg II 08814848190Roche Diagnostics GmbH · Test, hepatitis b (b core, be antigen, be antibody, b core igm)93 reports
- ARCHITECT 4P53-25Abbott Ireland Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)1 recall16 reports
- VITROS 6801925Ortho Clinical Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)1 recall15 reports
- ARCHITECT 1L82-27Abbott Ireland Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)1 recall4 reports
- VITROS 6801926Ortho Clinical Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)1 recall0 reports
- ARCHITECT 4P54-25Abbott Ireland Diagnostics · Test, hepatitis b (b core, be antigen, be antibody, b core igm)27 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page