Elecsys HBsAg II 08814848190Recalls & 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
Quick summary
This Roche Elecsys HBsAg II is a hepatitis B blood test. The 93 adverse event reports mention false positive and false negative results, plus results that could not be reproduced. There are no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 93
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 07613336168103), received between Aug 13, 2021 and Sep 29, 2026 — classified as 93 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (59 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 Result59
- Non Reproducible Results32
- False Negative Result16
- Incorrect, Inadequate or Imprecise Result or Readings7
- Contamination /Decontamination Problem2
- Improper or Incorrect Procedure or Method2
- Low Test Results2
- Output Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions92
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937690 ↗MalfunctionSep 28, 2026False Positive Result
There was an allegation of questionable Elecsys HBsAg II results for 1 patient sample on a cobas e 801 analytical unit compared to an Abbott analyzer.The initial result was 0.9 COI (borderline). The repeat result was 0.945 COI.The sample was repeated on an Abbott analyzer and the result was 0.0 IU/mL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917598 ↗MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915516 ↗MalfunctionSep 22, 2026False Positive Result; Non Reproducible Results
The initial reporter questioned a positive result for 1 patient sample tested for Elecsys HBsAg II (HBsAg II) on a cobas e 801 analytical unit. The initial result was 4.97 COI (positive).The repeat results were 0.338 COI (negative) and 0.365 COI (negative). The sample was repeated, and the result was 0.359 COI (negative).The sample was repeated on the customer¿s other cobas pro analyzer, and the results were 0.399 COI (negative) and 0.326 COI (negative).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857207 ↗MalfunctionSep 21, 2026False Positive Result; Non Reproducible Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846206 ↗MalfunctionSep 10, 2026Non Reproducible Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718093 ↗MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings
There was an allegation of questionable Elecsys HBsAg II results from the cobas e 411 disk analyzer.The customer stated that most of the HBsAg samples show low positive /borderline results at approximately 1 COI. This issue occurred repeatedly in multiple samples. No specific data or repeat testing results were provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713961 ↗MalfunctionAug 31, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50518999 ↗MalfunctionAug 17, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286936 ↗MalfunctionAug 17, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50272184 ↗MalfunctionAug 14, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50258555 ↗MalfunctionAug 13, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233745 ↗MalfunctionJul 30, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086585 ↗MalfunctionJul 13, 2026False Positive Result; High Test Results; Low Test Results; Non Reproducible Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25797847 ↗MalfunctionMay 7, 2026False Positive Result; Non Reproducible Results
THE INITIAL REPORTER ALLEGED FALSE REACTIVE AND BORDERLINE ELECSYS HBSAG II ASSAY RESULTS FOR THREE PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. PATIENT SAMPLE 1: THE INITIAL RESULT IS 0.920 COI (BORDERLINE). THE FIRST REPEAT RESULT IS 0.498 COI (NON-REACTIVE). THE SECOND REPEAT RESULT IS 0.537 COI (NON-REACTIVE). PATIENT SAMPLE 2: THE INITIAL RESULT IS 1.39 COI (REACTIVE). THE FIRST REPEAT RESULT IS 0.463 COI (NON-REACTIVE). THE SECOND REPEAT RESULT IS 0.458 COI (NON-REACTIVE). PATIENT SAMPLE 3: THE INITIAL RESULT IS 0.969 COI (BORDERLINE). THE FIRST REPEAT RESULT IS 0.443 COI (NON-REACTIVE). THE SECOND REPEAT RESULT IS 0.446 COI (NON-REACTIVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116335 ↗MalfunctionMay 1, 2026Insufficient Device Problem Information; Non Reproducible Results
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS HBSAG II ASSAY ON A COBAS E 801 ANALYTICAL UNIT. FOR QUANTITATIVE TEST ONLY: THIS DEVICE (HBSAG QUANTITATIVE) OR A SIMILAR DEVICE (HBSAG QUANTITATIVE) IS NOT CLEARED OR APPROVED FOR USE IN THE US. SAMPLE 1: THE QUALITATIVE TEST RESULT WAS 0.312 COI. THE QUANTITATIVE TEST RESULT WAS 0.168 IU/ML. SAMPLE 2 WAS ON (B)(6) 2026: THE QUALITATIVE TEST RESULTS WERE 1.16 COI AND 0.448 COI. THE QUANTITATIVE TEST RESULT WAS 92.4 IU/ML. SAMPLE 1 AND SAMPLE 2 WERE REPEATED FOR THE QUALITATIVE TEST, AND THE REPEAT RESULTS WERE BOTH NEGATIVE AND CONSISTENT WITH THE PATIENTS' PREVIOUS NEGATIVE HISTORY FOR HEPATITIS B VIRUS (HBV).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058361 ↗MalfunctionApr 29, 2026Non Reproducible Results
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS HBSAG II RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2026: THE INITIAL RESULT FROM THE ANALYZER USING THE FIRST REAGENT PACK WAS 0.506 COI (NON-REACTIVE). THE FIRST REPEAT RESULT FROM THE ANALYZER USING A SECOND REAGENT PACK WAS 0.540 COI (NON-REACTIVE). THE SECOND REPEAT RESULT FROM THE ABBOTT ALINITY WAS 88.29 S/CO (REACTIVE). THE THIRD REPEAT RESULT FROM THE ABBOTT ALINITY WAS 78.41 S/CO (REACTIVE). ON (B)(6) 2026: THE RESULT OF THE HEPATITIS B VIRUS POLYMERASE CHAIN REACTION (HBV PCR) ASSAY FROM THE COBAS C 6800 WAS "NON-REACTIVE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034125 ↗MalfunctionApr 24, 2026False Positive Result; Non Reproducible Results
THE INITIAL REPORTER ALLEGED INCREASED FALSE-REACTIVE (FALSE-POSITIVE) OR BORDERLINE ELECSYS HBSAG II RESULTS FOR SEVEN PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT, WHICH WERE NOT CONFIRMED (NON-REACTIVE OR NEGATIVE) ON RERUNS. PATIENT SAMPLE 1 ON (B)(6) 2026: THE INITIAL RESULT IS 0.94 COI. THE FIRST REPEAT RESULT IS 0.18 COI. THE SECOND REPEAT RESULT IS 0.16 COI. PATIENT SAMPLE 2 ON (B)(6) 2026: THE INITIAL RESULT IS 1.20 COI. THE FIRST REPEAT RESULT IS 0.23 COI. THE SECOND REPEAT RESULT IS 0.29 COI. PATIENT SAMPLE 3 ON (B)(6) 2026: THE INITIAL RESULT IS 1.47 COI. THE FIRST REPEAT RESULT IS 0.23 COI. THE SECOND REPEAT RESULT IS 0.26 COI. PATIENT SAMPLE 4 ON (B)(6) 2026: THE INITIAL RESULT IS 1.31 COI. THE FIRST REPEAT RESULT IS 0.24 COI. THE SECOND REPEAT RESULT IS 0.25 COI. PATIENT SAMPLE 5 ON (B)(6) 2026: THE INITIAL RESULT IS 0.90 COI. THE FIRST REPEAT RESULT IS 0.26 COI. THE SECOND REPEAT RESULT IS 0.18 COI. PATIENT SAMPLE 6 ON (B)(6) 2026: THE INITIAL RESULT IS 1.56 COI. THE FIRST REPEAT RESULT IS 0.35 COI. THE SECOND REPEAT RESULT IS 0.27 COI. PATIENT SAMPLE 7 ON (B)(6) 2026: THE INITIAL RESULT IS 2.48 COI. THE FIRST REPEAT RESULT IS 0.28 COI. THE SECOND REPEA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984728 ↗MalfunctionApr 23, 2026False Positive Result; Contamination /Decontamination Problem; Non Reproducible Results
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS HBSAG II ASSAY ON A COBAS E 801 MSB/MSBL ANALYZER. THE INITIAL RESULT WAS 4.11 COI (TESTED ON 1ST E 801 (SYSTEM B) AFTER CENTRIFUGATION AND INTERPRETED AS REACTIVE). THE 1ST REPEAT RESULT WAS 1.43 COI (TESTED ON A 2ND E 801 (SYSTEM A) AFTER CENTRIFUGATION AND INTERPRETED AS REACTIVE). THE 2ND REPEAT RESULT WAS 0.7 COI (TESTED ON A 3RD E 801 (EMERGENCY SYSTEM) AFTER HIGH-SPEED CENTRIFUGATION AND INTERPRETED AS NON-REACTIVE). ON (B)(6) 2026: THE HIGH-SPEED CENTRIFUGED SAMPLE WAS REPEATED: THE 3RD REPEAT RESULT WAS 0.545 COI (TESTED ON SYSTEM B). THE 4TH REPEAT RESULT WAS 0.563 COI (TESTED ON SYSTEM A). THE 5TH REPEAT RESULT WAS 0.556 COI (TESTED ON THE EMERGENCY SYSTEM). THE COMPLETE BLOOD COUNT (CBC) SAMPLE COLLECTED ON (B)(6) 2026 WAS TESTED: THE RESULTS WERE: 1.31 COI (TESTED ON SYSTEM B). 1.25 COI (TESTED ON SYSTEM A). 1.36 COI (TESTED ON THE EMERGENCY SYSTEM). AFTER HIGH-SPEED CENTRIFUGATION, THE RESULTS WERE: 1.04 COI (TESTED ON SYSTEM B). 0.982 COI (TESTED ON SYSTEM A). 1.04 COI (TESTED ON THE EMERGENCY SYSTEM). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY, AS THE RESULT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24964541 ↗MalfunctionApr 14, 2026False Positive Result; Contamination /Decontamination Problem; Non Reproducible Results
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HBSAG II RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 11.9 COI (REACTIVE). THE REPEAT RESULT WAS 0.274 COI (NON-REACTIVE). THE RESULT FROM ANOTHER COBAS E801 ANALYZER WAS 0.3 COI (NON-REACTIVE). THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24871783 ↗MalfunctionApr 9, 2026False Positive Result
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HBSAG II RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE AFFECTED PATIENT ALSO HAD QUESTIONABLE ELECSYS HBEAG AND ELECSYS® ANTI-HBC II RESULTS. THIS MEDWATCH WILL APPLY TO THE ELECSYS HBSAG II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) FOR THE ELECSYS HBEAG ASSAY AND MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) FOR THE ELECSYS® ANTI-HBC II ASSAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832985 ↗MalfunctionApr 8, 2026False Positive Result; Non Reproducible Results
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS HBSAG II ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 8.34 COI (POSITIVE). THE REPEAT RESULTS WERE 0.397 COI AND 0.357 COI (NEGATIVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816656 ↗MalfunctionMar 17, 2026Non Reproducible Results
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HBSAG II ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.03 COI (REACTIVE), ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 0.386 COI AND 0.327 COI (BOTH NON-REACTIVE), ACCOMPANIED BY A DATA FLAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621486 ↗MalfunctionMar 13, 2026Incorrect Measurement
THE INITIAL REPORTER QUESTIONED NEGATIVE [-] RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS HBSAG II (HBSAG II) ON A COBAS 8000 E 801 MODULE. PATIENT 1 INITIAL RESULT WAS [-] 0.0627 COI (NEGATIVE). THE REPEAT RESULT WAS 0.253 COI (NEGATIVE). PATIENT 2 INITIAL RESULT WAS [-] 0.005 COI (NEGATIVE). THE REPEAT RESULT WAS 0.243 COI (NEGATIVE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24598187 ↗MalfunctionFeb 27, 2026False Positive Result
THERE WAS AN ALLEGATION OF A FALSE-POSITIVE ELECSYS HBSAG II RESULT FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE PATIENT'S ELECSYS HBSAG RESULT WAS 2.98 COI (POSITIVE). THE PATIENT'S HBV DNA TEST RESULT WAS NEGATIVE. THE PATIENT'S ANTI-HBS, HBEAG, ANTI-HBE, AND ANTI-HBC RESULTS WERE NEGATIVE. THE SAMPLE WAS TESTED AT ANOTHER FACILITY USING ANOTHER COBAS E 801 MODULE, AND THE ELECSYS HBSAG RESULT WAS CONSISTENT WITH THE INITIAL RESULT (POSITIVE). THE NUMERICAL VALUE FOR THE RESULT WAS NOT PROVIDED. THE HBSAG RESULT WITH THE ABBOTT METHOD WAS 0.01 IU/ML (NEGATIVE). A CONFIRMATORY TEST WAS NOT PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474955 ↗
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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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