Elecsys HBsAg II Auto Confirm 08741034190Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613336172902), received between Aug 13, 2021 and Sep 14, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752071 ↗
• MalfunctionAug 17, 2026False Positive Result

  The initial reporter stated they received questionable positive results for one patient sample tested with Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm on two cobas e 801 analytical unit analyzers.This MedWatch will apply to the Elecsys HBsAg II Auto Confirm reagent. Please refer to the MedWatch with A1 patient identifier (b)(6) for information related to the Elecsys HBsAg II reagent.The sample resulted in HBsAg values of 1.3 COI (reactive) and 1.38 COI (reactive) when tested on the e 801 systems. The HBsAg Auto confirm result was 24 % (reactive) on one of the e 801 systems.The sample was tested with a PCR method and the HBV PCR result was non-reactive.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50272181 ↗
• MalfunctionJul 27, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50005409 ↗
• MalfunctionMar 6, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HBSAG II AUTO CONFIRM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE WAS INVALID WITH THE ELECSYS HBSAG II AUTO CONFIRM. IT WAS ALLEGED THAT THE SAMPLE'S ELECSYS HBSAG II RESULTS WERE REPEATEDLY REACTIVE. THE SAMPLE'S ELECSYS HBSAG II RESULTS WERE 0.97 COI, 1.03 COI, AND 0.47 COI. THE HBSAG CONFIRMATION TEST IS USED TO VERIFY THE HBSAG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536401 ↗
• MalfunctionOct 15, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE FALSE NEGATIVE ELECSYS HBSAG II AUTO CONFIRM RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE ELECSYS HBSAG II AUTO CONFIRM ASSAY HAS EMBEDDED APPLICATIONS WITHIN IT. THE CNHBSAG2 IS AN EMBEDDED APPLICATION THAT HAS A REACTION WITH THE CONTROL PRETREATMENT IN THE ELECSYS HBSAG II AUTO CONFIRM ASSAY. THE CFHBSAG2 IS AN EMBEDDED APPLICATION THAT HAS A REACTION WITH CONFIRMATORY PRETREATMENT IN THE ELECSYS HBSAG II AUTO CONFIRM ASSAY. THE INITIAL HBSAG RESULT WAS 37.3 COI (REACTIVE), WITH A REPEAT RESULT OF 37.4 COI (REACTIVE). CONFIRMATORY TESTING WAS COMPLETED WITH THE FOLLOWING RESULTS: A CFHBSAG2 RESULT OF 51.8 COI (REACTIVE). A CNHBSAG2 RESULT OF 55.0 COI (REACTIVE). THE HBSAG II AUTO CONFIRM RESULT WAS 94.3% (NON-REACTIVE). THE HBS ANTIGEN WAS POSITIVE WITH THE VIDAS METHOD. CONFIRMATORY TESTING WAS NOT COMPLETED WITH THE VIDAS METHOD. THE HBV VIRAL LOAD WAS MEASURED AND WAS HIGHLY POSITIVE (>9 LOG). ANOTHER SAMPLE ON (B)(6) 2025 GAVE AN HBSAG QUANTITATIVE RESULT OF 459507 IU/ML. A SAMPLE COLLECTED FROM THE SAME BLOOD DRAW, TESTED ON (B)(6) 2025, TESTED FOR HBSAG WITH A DILUTION OF 1:1000, HAD A RESULT OF 2510 COI (REACTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302780 ↗
• MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Appropriate Device Problem Term/Code Not Available; Incorrect, Inadequate or Imprecise Result or Readings; Appropriate Device Problem Term/Code Not Available

  THE INITIAL REPORTER ALLEGED THAT ONE PATIENT SAMPLE TESTED REACTIVE FOR HBSAG G2 CONFIRMATORY ELECSYS E2G ON THE COBAS PURE E 402 ANALYTICAL UNIT. THE RESULT WAS CONFIRMED USING THE HBSAG II CONFIRMATORY ASSAY. ADDITIONALLY, THE SAMPLE TESTED POSITIVE FOR ANTI-HBS AND ANTI-HBC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065051 ↗
• MalfunctionAug 20, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HBSAG II AUTO CONFIRM RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL HBSAG RESULT WAS 1.14 COI, INTERPRETED AS REACTIVE. THE SAME WAS REPEATED AND THE RESULT WAS 0.974 COI, INTERPRETED AS INDETERMINATE. THE CONFIRMATORY TEST WAS PERFORMED AND THE RESULT WAS 42.2%, INTERPRETED AS REACTIVE. THE SAMPLE WAS REPEATED AGAIN AND THE HBSAG RESULT WAS 0.88 COI, INTERPRETED AS NON-REACTIVE. ANOTHER PATIENT SAMPLE COLLECTED AT THE SAME TIME WAS ALSO TESTED FOR HBSAG AND THE RESULT WAS 0.782 COI, INTERPRETED AS NON-REACTIVE. THE CONFIRMATORY TEST WAS PERFORMED AND THE RESULT WAS 42.5%, INTERPRETED AS INDETERMINATE. THE ORIGINAL SAMPLE WAS REPEATED THREE MORE TIMES AND THE RESULTS WERE 0.625 COI, 0.624 COI, AND 0.624 COI, ALL INTERPRETED AS NON-REACTIVE. THE PATIENT SAMPLES WERE RE-CENTRIFUGED PRIOR TO EVERY TEST. THE PATIENT SAMPLE WAS ALSO TESTED ON A MINI VIDAS ANALYZER AND THE HBSAG RESULT WAS NON-REACTIVE. THE NON-REACTIVE RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850389 ↗
• MalfunctionJul 10, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HBSAG II AUTO CONFIRM RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.36 COI (POSITIVE), AND THE REPEAT RESULT WAS 1.22 COI (POSITIVE). AN AUTO CONFIRMATION TEST RESULT WAS 37% AND CONFIRMED TO BE REACTIVE. DUE TO THE PATIENT'S HISTORY THE DOCTOR REQUESTED A NEW SAMPLE FROM THE PATIENT. ON (B)(6) 2025, ON THE SAME COBAS PRO THE RESULTS OF THE HBSAG AND THE AUTO CONFONFIRMATION, WERE BOTH REACTIVE. THEY WERE THEN TESTED ON ABBOTT ANALYZERS AND THE RESULTS WERE NEGATIVE. ON (B)(6) 2025, BOTH THE FIRST AND SECOND SAMPLES WERE ALIQUOTED AND SENT TO TWO SEPARATE LABS, BOTH USING E 801 ANALYZERS AND THE RESULTS WERE NEGATIVE, WITH RESULTS AROUND 0.6 COI FOR BOTH SAMPLES. ONE OF THE LABS ALSO PERFORMED AUTO CONFONFIRMATION TESTING, WITH INDETERMINATE RESULTS FOR BOTH SAMPLES. THE SAMPLES WERE BOTH REPEATED ON (B)(6) 2025. THE FIRST SAMPLES HBSAG RESULT WAS 0.633 COI (NON-REACTIVE), HBSAG2CL: 58% (INDETERMINATE) THE SECOND SAMPLES HBSAG RESULT WAS 0.75 COI (NON-REACTIVE), HBSAG2CL: 60.3% .(CONFIRMATION NOT VALID)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468900 ↗
• MalfunctionAug 13, 2021Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH THE ELECSYS (B)(6) GEN. 2 IMMUNOASSAY ON A COBAS 8000 E 801 MODULE. THE FIRST SAMPLE ALSO HAD A QUESTIONABLE ELECSYS (B)(6) GEN. 2 AUTO CONFIRM RESULT ON A SECOND E 801 ANALYZER. THIS MEDWATCH WILL APPLY TO THE (B)(6) AUTO CONFIRM ASSAY. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE (B)(6) ASSAY. ON (B)(6) 2021, A FIRST SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A (B)(6) RESULT OF (B)(6). THE SAMPLE WAS REPEATED AND THE RESULT WAS ALSO (B)(6). THE SAMPLE WAS TESTED ON A SECOND E 801 ANALYZER, RESULTING IN A (B)(6) VALUE FOR THE (B)(6) AUTO CONFIRM ASSAY. ON (B)(6) 2021, A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A (B)(6) RESULT OF (B)(6). THE SAMPLE WAS REPEATED AND THE RESULT WAS ALSO (B)(6). THE SERIAL NUMBER OF THE FIRST E 801 ANALYZER IS (B)(4). THE SERIAL NUMBER OF THE SECOND E 801 ANALYZER WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317533 ↗