Elecsys HBsAg II 08814856160Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336198285), received between Sep 15, 2025 and Aug 5, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (2 reports).
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
- False Positive Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50139204 ↗MalfunctionSep 15, 2025False Positive Result; False Positive Result
THE INITIAL REPORTER ALLEGED HIGH PATIENT RECOVERY AND FALSE-POSITIVE RESULTS WITH THE HBSAG G2 ELECSYS COBAS E 100 V2 ASSAY ON THE COBAS E411 DISK. THE FIRST INSTANCE INVOLVED A PATIENT SAMPLE TESTED ON (B)(6) 2021. THE INITIAL RESULT WAS 1.92 (REACTIVE). A FIRST RERUN ON THE PRIMARY TUBE YIELDED 0.308 (NON-REACTIVE), AND A SECOND RERUN FROM A HITACHI CUP YIELDED 0.310 (NON-REACTIVE). THE SECOND INSTANCE INVOLVED ANOTHER PATIENT SAMPLE DRAWN AND TESTED ON (B)(6) 2021. THE INITIAL RESULT WAS 1.24 (REACTIVE). A FIRST RERUN ON THE PRIMARY TUBE YIELDED 0.355 (NON-REACTIVE), AND A SECOND RERUN YIELDED 0.332 (NON-REACTIVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058000 ↗
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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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