Elecsys HBsAg II 08814864160Recalls & reported problems
Roche Diagnostics GmbH · Class 2
All models of Elecsys HBsAg II (5)
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 07613336198278), received between Nov 21, 2022 and Nov 21, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Negative Result” (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
- False Negative Result1
Patient problems
- Hepatitis1
- 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.
MalfunctionNov 21, 2022False Negative Result; False Negative Result
THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE NEGATIVE HBSAG G2 ELECSYS RESULTS FROM COBAS 8000 COBAS E 602 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 0.75 COI (NEGATIVE). THE CUSTOMER RECENTRIFUGED THE SAMPLE AND REPEATED TESTING WITH A RESULT OF <1.0 COI (NEGATIVE) REPEATEDLY. THE CUSTOMER TESTED THE SAMPLE ON AN ABBOTT ARCHITECT AND RECEIVED 1.02 (POSITIVE) FOR THE SCREENING TEST AND 87.64% (POSITIVE) FOR THE CONFIRMATION. THE PHYSICIAN BELIEVED THE RESULTS FROM ABBOTT AND THAT THE PATIENT IS HEPATITIS POSITIVE AS HE TESTED POSITIVE FIVE MONTHS AGO FOR HEP CORE ASSAY.
Patient problems: Hepatitis; No Clinical Signs, Symptoms or Conditions
MAUDE report 15833469 ↗
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.
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