Elecsys HBsAg II 08814848162Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336183076), received between Nov 17, 2025 and Sep 23, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026False Positive Result

  There was an allegation of questionable results with the Elecsys HBsAg II assay for a donor sample tested on the Roche instrument (details have been requested). It was reported that the patient has always been non-reactive on a non-Roche instrument. Since switching to Roche instruments, the last two times the patient has been reactive for HBsAg but then confirmed negative for HBsAg.The test was repeated as the reactive result did not match previous history.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870259 ↗
• MalfunctionMay 29, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HBSAG II AND ELECSYS HIV DUO RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL ELECSYS HIV DUO RESULT WAS REACTIVE. ON (B)(6) 2026, THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING. THE CONFIRMATORY HIV (GEENIUS METHOD) TEST RESULT WAS "CONFIRMED NON-REACTIVE". THE INITIAL ELECSYS HBSAG II RESULT WAS REACTIVE. ON (B)(6) 2026, THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING. THE CONFIRMATORY (ROCHE E801 ECLIA METHOD) TEST RESULT WAS "CONFIRMED NON-REACTIVE". THE SAMPLE WAS REPEATED BECAUSE OF THE INITIALLY REACTIVE RESULTS. THIS MEDWATCH WILL APPLY TO THE ELECSYS HBSAG II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS HIV DUO ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333764 ↗
• MalfunctionMay 29, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HBSAG II AND ELECSYS HIV DUO RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL ELECSYS HIV DUO RESULT WAS REACTIVE. ON (B)(6) 2026, THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING. THE CONFIRMATORY HIV (GENIUS METHOD) TEST RESULT WAS "CONFIRMED NON-REACTIVE". THE INITIAL ELECSYS HBSAG II RESULT WAS REACTIVE. ON(B)(6) 2026, THE SAMPLE WAS SENT FOR CONFIRMATORY TESTING. THE CONFIRMATORY (ROCHE E801 ECLIA METHOD) TEST RESULT WAS "CONFIRMED NON-REACTIVE". THIS MEDWATCH WILL APPLY TO THE ELECSYS HBSAG II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS HIV DUO ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333761 ↗
• MalfunctionNov 17, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF FALSE-POSITIVE ELECSYS HBSAG II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.993 COI (REACTIVE). THE SAMPLE WAS REPEATED, AND THE RESULTS WERE 0.962 COI (REACTIVE) AND 0.907 COI (REACTIVE). ON (B)(6) 2025, CONFIRMATORY TESTING CONFIRMED THAT THE SAMPLE WAS NON-REACTIVE. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT, AND THE ELECSYS HBSAG II RESULT WAS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571006 ↗
• MalfunctionNov 17, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF FALSE-POSITIVE ELECSYS HBSAG II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.02 COI (REACTIVE). THE SAMPLE WAS REPEATED, AND THE RESULTS WERE 1.01 COI (REACTIVE) AND 0.998 COI (REACTIVE). ON (B)(6) 2025, CONFIRMATORY TESTING CONFIRMED THAT THE SAMPLE WAS NON-REACTIVE. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT, AND THE ELECSYS HBSAG II RESULT WAS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570375 ↗