Elecsys Anti-HBe 07026838190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04015630940134), received between Jan 9, 2024 and Jul 28, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026False Positive Result; Device Damaged Prior to Receipt by User

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053271 ↗
• MalfunctionMar 3, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HBE RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO AN ABBOTT ALINITY ANALYZER. ON (B)(6) 2026, THE INITIAL ANTI-HBE RESULT WAS 0.813 COI, INTERPRETED AS REACTIVE. THE REPEAT RESULT AFTER RECENTRIFUGATION OF THE PATIENT SAMPLE WAS 0.765 COI, INTERPRETED AS REACTIVE. THESE RESULTS WERE DEEMED "FALSE POSITIVES", AS THE PATIENT'S OTHER HEPATITIS B MARKERS WERE "NEGATIVE". ON (B)(6) 2026, THE REPEAT RESULT OF A PORTION OF THE PATIENT'S SERUM SAMPLE TESTED ON THE ABBOTT ALINITY ANALYZER WAS 1.58 S/CO, INTERPRETED AS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500046 ↗
• MalfunctionSep 17, 2025False Positive Result; High Test Results; False Positive Result; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HBE AND ELECSYS ANTI-HBC II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER ANTI-HBE. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-HBC II RESULTS. ON (B)(6) 2025, THE INITIAL ANTI-HBE RESULT WAS 0.732 COI, INTERPRETED AS POSITIVE, AND THE INITIAL ANTI-HBC RESULT WAS 0.212 COI, INTERPRETED AS REACTIVE. THE CUSTOMER QUESTIONED THE RESULTS AS THEY WERE INCONSISTENT WITH THE PATIENT'S CLINICAL SYMPTOMS WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER COMPETITOR ANALYZER AND THE ANTI-HBE RESULT WAS 1.26 COI INTERPRETED AS NON-REACTIVE, AND THE ANTI-HBC RESULT WAS 3.99 COI, INTERPRETED AS NON-REACTIVE. ON (B)(6) 2025, A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND THE ANTI-HBE RESULT WAS 0.820 COI, INTERPRETED AS REACTIVE, AND THE INITIAL ANTI-HBC RESULT WAS 0.212 COI, INTERPRETED AS REACTIVE. THE SAMPLE WAS ALSO REPEATED ON THE COMPETITOR ANALYZER AND THE ANTI-HBE RESULT WAS 1.23 COI, INTERPRETED AS NON-REACTIVE, AND THE INITIAL ANTI-HBC RESULT WAS 4.13 COI, INTERPRETED AS NON-REACTIVE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074092 ↗
• MalfunctionMar 26, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-HBE RESULTS FROM FOUR PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. TWO EXAMPLES OF DISCREPANT RESULTS WERE PROVIDED: PATIENT SAMPLE 1 THE INITIAL RESULT FROM THE ANALYZER WAS 0.64 CUT-OFF INDEX (COI). THE FIRST REPEAT RESULT FROM THE ANALYZER AFTER HIGH-SPEED CENTRIFUGATION WAS THE SAME. THE SECOND REPEAT RESULT FROM A "DOMESTIC INSTRUMENT" WAS 1.24 PEIU/ML (NEGATIVE). PATIENT SAMPLE 2 THE INITIAL RESULT FROM THE ANALYZER WAS 0.22 COI. THE FIRST REPEAT RESULT FROM THE ANALYZER AFTER HIGH-SPEED CENTRIFUGATION WAS THE SAME. THE SECOND REPEAT RESULT FROM A "DOMESTIC INSTRUMENT" WAS 0.98 PEIU/ML (NEGATIVE). THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, ALERTING THEM TO AN ISSUE WITH THE RESULTS. THE REPEAT RESULTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697048 ↗
• MalfunctionFeb 11, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE POSITIVE ELECSYS ANTI-HBE RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT THAT DID NOT MATCH THE DIAGNOSIS OF THE PATIENT. THE CUSTOMER SUSPECTED AN INTERFERENCE. THE RESULT WAS 0.00611 COI AND WAS CONFIRMED BY TWO REPEAT TESTS WITH THE SAME RESULT (0.00625 COI AND 0.00618 COI). RESULTS FOR THE ENTIRE HEPATITIS B PROFILE FOR THE SAME PATIENT SAMPLE WERE ALL NEGATIVE. AHBS RESULT WAS <2 IU/L. AHCV RESULT WAS 0.033 COI (NEGATIVE). HBE_AG RESULT WAS 0.0812 COI (NEGATIVE). HBSAG RESULT WAS 0.365 COI (NEGATIVE). AHBC WAS 1.34 COI (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354454 ↗
• MalfunctionDec 5, 2024False Positive Result; Incorrect Measurement; False Positive Result; Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HBE RESULTS FOR ONE PATIENT FROM THE COBAS E801 MODULE. REFER TO THE ATTACHMENT TO THE MEDWATCH WITH A1-PATIENT IDENTIFIER PT-0072613 FOR THE PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858137 ↗
• MalfunctionOct 24, 2024False Positive Result; Device Contamination with Body Fluid; False Positive Result; Device Contamination with Body Fluid

  ROCHE DIAGNOSTICS RECEIVED A CUSTOMER COMPLAINT REGARDING AN ALLEGED QUESTIONABLE POSITIVE ELECSYS ANTI-HBE ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 E801 ANALYZER. THE PATIENT SAMPLE RESULTED IN ANTI-HBE VALUES OF 0.002 COI (POSITIVE) AND 0.002 COI (POSITIVE) WHEN MEASURED ON THE ANALYZER. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED NEGATIVE FOR ANTI-HBE WHEN MEASURED ON THE ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525230 ↗
• MalfunctionMay 6, 2024False Negative Result; False Positive Result; Non Reproducible Results; False Negative Result; False Positive Result; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-HBE (ANTI-HBE) RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS 8000 CORE UNIT. THE REPORTER WAS COMPARING THE PERFORMANCE OF THE ASSAY'S TWO REAGENT LOTS: REAGENT LOT A (OLD REAGENT LOT) AND REAGENT LOT B (NEW REAGENT LOT). THE INITIAL POSITIVE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER CONSIDERED THE INITIAL POSITIVE RESULTS INCORRECT. SAMPLE ID (B)(6) ON (B)(6) 2024: THE INITIAL RESULT FROM THE ANALYZER USING REAGENT LOT A WAS 0.850 CUT-OFF INDEX COI (POSITIVE). ON (B)(6) 2024: THE FIRST REPEAT RESULT FROM THE ANALYZER USING REAGENT LOT B WAS 1.09 COI (NEGATIVE). THE SECOND REPEAT RESULT FROM THE ANALYZER USING REAGENT LOT B AFTER CENTRIFUGATION AND RECALIBRATION WAS 1.09 COI (NEGATIVE). ON (B)(6) 2024: THE THIRD REPEAT RESULT FROM ANOTHER LABORATORY USING REAGENT LOT B WAS 1.05 COI (NEGATIVE). THE FOURTH REPEAT RESULT FROM ANOTHER LABORATORY USING REAGENT LOT B WAS 1.04 COI (NEGATIVE). SAMPLE ID (B)(6) ON (B)(6) 2024: THE INITIAL RESULT FROM THE ANALYZER USING REAGENT LOT A WAS 0.866 ROUNDED OFF TO 0.87 COI (POSITIVE). ON (B)(6) 2024: THE FIRST REPEAT RESULT FROM THE ANALYZER USING REAGENT LOT B WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247180 ↗
• MalfunctionMar 11, 2024False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF FALSE POSITIVE ELECSYS ANTI-HBE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.637 COI (REACTIVE). THE REPEATED RESULT WAS 0.648 COI (REACTIVE). CALIBRATION WAS PERFORMED AND THE SAMPLE WAS RETESTED. THE RESULTS AFTER CALIBRATION WERE 0.743 COI (REACTIVE) AND 0.718 COI (REACTIVE). THE RESULTS DID NOT FIT THE CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS TESTED USING ANOTHER METHOD (ABBOTT ALINITY) AND THE RESULT WAS 2.06 (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18873768 ↗
• MalfunctionJan 9, 2024False Positive Result; False Positive Result

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FROM 2 SAMPLES FROM 1 PATIENT TESTED FOR ELECSYS ANTI-HBE (ANTI-HBE) ON A COBAS PURE E 402 ANALYTICAL UNIT. ON (B)(6) 2023 THE RESULT FROM THE E402 ANALYZER WAS (B)(6) (POSITIVE). THE SAMPLE WAS SENT TO A REFERENCE LABORATORY WHERE THE RESULT FROM A COMPETITOR METHOD WAS "NEGATIVE." THE ACTUAL RESULT WAS NOT PROVIDED. ON (B)(6) 2023 THE RESULT FROM THE E402 ANALYZER WAS POSITIVE. THE ACTUAL RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477034 ↗