Elecsys Anti-HBc II 09014926160Recalls & 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 07613336203613), received between Oct 10, 2024 and Oct 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “False Positive 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.
Reports received per month
Most reported problems
Device problems
- False Positive Result1
- Insufficient Device Problem Information1
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.
MalfunctionOct 10, 2024False Positive Result; Insufficient Device Problem Information; False Positive Result; Insufficient Device Problem Information
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM FOUR PATIENTS TESTED WITH ELECSYS ANTI-HBC IGM AND ELECSYS ANTI-HBC II. THE RESULTS MEASURED BY EACH ASSAY WERE ALLEGED TO BE INCONSISTENT WITH EACH OTHER. THIS MEDWATCH WILL APPLY TO THE ELECSYS ANTI-HBC II REAGENT. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS ANTI-HBC IGM REAGENT. ALL FOUR PATIENTS HAD MULTIPLE SAMPLES DRAWN AT THE SAME TIME. ALL SAMPLES HAD POSITIVE ANTI-HBC IGM RESULTS, BUT NEGATIVE ANTI-HBC RESULTS. NO SPECIFIC DATA WAS PROVIDED. THE PATIENTS' RESULTS WERE REPORTED TO THE MEDICAL DIRECTOR. THE MEDICAL DIRECTOR REVIEWED THE CASES AND REPORTED THE PATIENTS AS NEGATIVE FOR HEPATITIS B BASED ON THE ANTI-HBC RESULTS, PATIENT HISTORY, AND CLINICAL HEALTH OF THE PATIENTS AT THE TIME OF SAMPLE COLLECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20421508 ↗
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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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