Elecsys HBsAg Confirmatory Test 11820648122Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630911110), received between Feb 2, 2023 and Sep 17, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED DISCREPANT REACTIVE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS HBSAG II ASSAY AND THE ELECSYS HBSAG CONFIRMATORY TEST ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2022, THE ELECSYS HBSAG II ASSAY GENERATED A RESULT OF 1.51 COI (REACTIVE), AND THE ELECSYS HBSAG CONFIRMATORY TEST ALSO GENERATED A REACTIVE RESULT. ADDITIONAL TESTING ON THE SAME SAMPLE USING THE ELECSYS ANTI-HBS (AHBS) ASSAY PRODUCED A RESULT OF 2.0 IU/L (NON-REACTIVE). TESTING OF DIFFERENT BLOOD DRAWS FROM THE SAME PATIENT WAS CONDUCTED ON (B)(6) 2022 USING COMPETITOR SYSTEMS (ABBOTT AND SIEMENS). BOTH SYSTEMS REPORTED NON-REACTIVE RESULTS FOR HBSAG AND AHBS. NO FURTHER RESULT DETAILS WERE PROVIDED FOR THESE TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073717 ↗
• MalfunctionSep 16, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER ALLEGED INACCURACY IN RESULTS OBTAINED WITH THE HBSAG CONFIRMATORY TEST ELECSYS ON THE COBAS E 801 MODULE. THE SAMPLE WAS INITIALLY TESTED FOR HBSAG WITH RESULTS OF 1.93 COI AND 1.37 COI UPON REPETITION. THE SAMPLE WAS SUBSEQUENTLY TESTED USING THE HBSAG CONFIRMATORY TEST IN TWO SEPARATE SESSIONS. IN THE FIRST SESSION, THE SAMPLE WITH CONTROL REAGENT YIELDED A RESULT OF 0.888 COI, AND THE SAMPLE WITH CONFIRMATORY REAGENT YIELDED A RESULT OF 0.328 COI. CONTROL 2 WITH CONTROL REAGENT YIELDED A RESULT OF 3.96 COI, AND CONTROL 2 WITH CONFIRMATORY REAGENT YIELDED A RESULT OF 0.530 COI. IN THE SECOND SESSION, THE SAMPLE WITH CONTROL REAGENT YIELDED A RESULT OF 0.870 COI, AND THE SAMPLE WITH CONFIRMATORY REAGENT YIELDED A RESULT OF 0.359 COI. CONTROL 2 WITH CONTROL REAGENT YIELDED A RESULT OF 4.13 COI, AND CONTROL 2 WITH CONFIRMATORY REAGENT YIELDED A RESULT OF 0.526 COI. THE SAMPLE WAS REPORTED AS REACTIVE. TESTING OF THE SAME PATIENT SAMPLE AT A DIFFERENT LABORATORY YIELDED A NEGATIVE HBSAG RESULT, WHICH WAS CONFIRMED BY MOLECULAR TESTING. THE CUSTOMER INDICATED THAT THE INITIAL DILUTION OF THE SAMPLE WITH CONFIRMATORY AND CONTROL REAGENTS WAS PERFORMED CORRECTLY AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066832 ↗
• MalfunctionMay 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER QUESTIONED NEGATIVE RESULTS FOR 4 PATIENT SAMPLES TESTED FOR ELECSYS HBSAG CONFIRMATORY TESTS (HBSAG CONFIRMATORY) ON A COBAS E 801 ANALYTICAL UNIT WHERE THE INITIAL HBSAG RESULTS WERE HIGH (POSITIVE). OF THE DATA PROVIDED, DISCREPANT RESULTS WERE IDENTIFIED FOR 1 PATIENT SAMPLE BETWEEN 2 DIFFERENT HBSAG CONFIRMATORY REAGENTS. THIS MEDWATCH WILL COVER HBSAG CONFIRMATORY REAGENT WITH MATERIAL NUMBER 11820648122. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE HBSAG CONFIRMATORY REAGENT WITH MATERIAL NUMBER 09127127190. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311832 ↗
• MalfunctionFeb 2, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HBSAG CONFIRMATORY TEST RESULTS FOR 4 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER SUSPECTS THAT THE HBSAG CONFIRMATORY RESULTS ARE FALSE POSITIVE IN RELATION TO THE ANTI-HEPATITIS B SURFACE ANTIBODY AND ANTI-HEPATITIS B CORE ANTIBODY RESULTS. THEY WERE QUESTIONING WHETHER THIS PATTERN OF RESULTS WAS POSSIBLE. ON (B)(6) 2022, PATIENT B'S SAMPLE WAS TESTED ON LINE C AND HAD TWO REACTIVE HBSAG TEST RESULTS. THE FIRST RESULT WAS 2.04 COI AND THE SECOND RESULT AFTER RE-CENTRIFUGATION WAS 1.82 COI. THE HBSAG CONFIRMATORY TEST WAS PERFORMED AND THE RESULT WAS REACTIVE WITH A QUANTITATIVE RESULT OF 0.436. THE ANTI-HEPATITIS B SURFACE ANTIBODY RESULT WAS NON-REACTIVE WITH A QUANTITATIVE RESULT OF <2 MIU/ML. THE ANTI-HEPATITIS B CORE ANTIBODY RESULT WAS NON-REACTIVE WITH A QUANTITATIVE RESULT OF 2.02 COI. PATIENT C'S SAMPLE WAS TESTED ON LINE C AND HAD THREE REACTIVE HBSAG TEST RESULTS. THE FIRST RESULT WAS 1.5 COI, THE SECOND RESULT WAS 1.56 COI, AND THE THIRD RESULT AFTER RE-CENTRIFUGATION WAS 1.5 COI. THE HBSAG CONFIRMATORY TEST WAS PERFORMED AND THE RESULT WAS REACTIVE WITH A QUANTITATIVE RESULT OF 0.474. THE ANTI-HEPATIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16285810 ↗