Elecsys HBsAg II 07251076190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630940028), received between Sep 16, 2025 and Sep 19, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (3 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE REACTIVE ELECSYS HBSAG II RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 1.06 COI, AND THE REPEAT RESULT WAS 0.48 COI. THE CUSTOMER BELIEVES THE RESULT OF 0.48 COI IS CORRECT. THE INITIAL RESULT TRIGGERED AN ALARM ON THE ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096948 ↗
• MalfunctionSep 18, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE ELECSYS HBSAG II ASSAY ON THE COBAS E 801 MODULE FOR TWO PATIENT SAMPLES. FOR SAMPLE 1, TESTING ON (B)(6) 2020 YIELDED A RESULT OF -0.0942 (NEGATIVE). SUBSEQUENT TESTING ON (B)(6) 2020 PRODUCED RESULTS OF -0.0987 (NEGATIVE), -0.0809 (NEGATIVE), -0.0598 (NEGATIVE), -0.0546 (NEGATIVE), 0.0998 (NEGATIVE), AND -0.114 (NEGATIVE) ACROSS VARIOUS TUBES AND MATRICES, INCLUDING PLASMA AND SERUM. FOR SAMPLE 2, TESTING ON (B)(6) 2020 YIELDED A RESULT OF -0.00032 (NEGATIVE) IN SERUM. ON (B)(6) 2020, TESTING OF THE SAME SAMPLE IN PLASMA PRODUCED A RESULT OF 0.275 (POSITIVE). THE RESULTS WERE NOT CONFIRMED WITH AN HBSAG CONFIRMATORY TEST. NO ADDITIONAL CONFIRMATORY TESTING WAS PERFORMED, AND THE POSITIVE RESULT FOR SAMPLE 2 COULD NOT BE REPRODUCED. THE RESULTS WERE NOT REPORTED TO THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084508 ↗
• MalfunctionSep 17, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED A FALSE POSITIVE RESULT FOR THE HBSAG G2 ELECSYS E2G 300 ASSAY ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL TEST RESULT WAS 1.61 COI (REACTIVE), WHILE TWO REPEAT TESTS IN THE SAME RUN YIELDED RESULTS OF 0.327 COI AND 0.315 COI (BOTH NON-REACTIVE). THESE TESTS WERE PERFORMED USING THE E-FLOW PROCESS. THE SAME SAMPLE WAS SUBSEQUENTLY PROCESSED MANUALLY IN A HITACHI CUP, YIELDING A RESULT OF 0.321 COI (NON-REACTIVE). THE SAMPLE WAS COLLECTED THE DAY PRIOR TO TESTING, AND THE CUSTOMER EXCLUDED INCOMPLETE COAGULATION AS A POTENTIAL CAUSE. THE RESULTS WERE INTERPRETED AS NON-REACTIVE BASED ON THE REPEAT TESTING OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073485 ↗
• MalfunctionSep 16, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE HBSAG G2 ELECSYS E2G 300 ASSAY ON THE COBAS E 801 MODULE. THE CUSTOMER REPORTED THAT ONE PATIENT SAMPLE INITIALLY TESTED POSITIVE BUT WAS LATER DETERMINED TO BE NEGATIVE BASED ON CONFIRMATORY TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065074 ↗