Elecsys Anti-HBc IgM 07026811160Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336153932), received between Oct 10, 2024 and Feb 12, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (4 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.

• MalfunctionFeb 12, 2025False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ANTI-HBC IGM ON A COBAS E801 ANALYTICAL UNIT AND NOT CORRELATING TO ELECSYS ANTI-HBC TOTAL RESULT. THE SAMPLE WAS INITIALLY TESTED TWICE AT THE SAME TIME. THE INITIAL RESULTS WERE 4.45 COI AND 4.469 COI AND THEY WERE INTERPRETED AS POSITIVE. THE CUSTOMER ALWAYS TESTS FOR ANTI-HBC TOTAL WHEN INITIALLY TESTING FOR ANTI-HBC IGM. ANTI-HBC TOTAL RESULT: NEGATIVE. THE SAMPLE WAS THEN REPEATED RESULTING IN AN ANTI-HBC IGM VALUE OF 1.93 COI. THE NEGATIVE RESULT OF ANTI-HBC TOTAL WAS DEEMED TO BE CORRECT AND REPORTED TO THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363262 ↗
• MalfunctionJan 6, 2025False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR APPROXIMATELY 7 PATIENT SAMPLES TESTED USING TWO DIFFERENT LOT NUMBERS OF ELECSYS ANTI-HBC IGM ON A COBAS E 801 ANALYTICAL UNIT. FOR APPROXIMATELY 5 PATIENT SAMPLES TESTED USING ANTI-HBC IGM REAGENT LOT NUMBER 81987901 (EXPIRATION DATE = 31-MAY-2025), ALL SAMPLES HAD POSITIVE ANTI-HBC IGM RESULTS AND NEGATIVE RESULTS FOR ANTI-HBC TOTAL. THE CUSTOMER STATED IT WAS NOT POSSIBLE FOR SAMPLES TO HAVE POSITIVE ANTI-HBC IGM RESULTS WITH NEGATIVE ANTI-HBC TOTAL RESULTS. A SECOND ANTI-HBC IGM REAGENT LOT NUMBER WAS SENT TO THE CUSTOMER. THIS REAGENT LOT NUMBER IS UNKNOWN. TWO SUBSEQUENT SAMPLES (SAMPLES 6 AND 7) WERE TESTED USING THIS NEW REAGENT AND BOTH SAMPLES HAD POSITIVE ANTI-HBC IGM RESULTS AND NEGATIVE ANTI-HBC TOTAL RESULTS. THE CUSTOMER DID NOT ALLEGE THERE WERE ANY ISSUES WITH THE ANTI-HBC TOTAL ASSAY RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079494 ↗
• MalfunctionNov 7, 2024False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ONGOING ISSUES WITH QUESTIONABLY POSITIVE PATIENT RESULTS FOR APPROXIMATELY 30 PATIENT SAMPLES TESTED WITH ELECSYS ANTI-HBC IGM (HBIM) ON TWO COBAS E 801 ANALYTICAL UNIT ANALYZERS BETWEEN (B)(6) 2024 AND (B)(6) 2024. SOME HAD RESULTS BETWEEN 10 AND 20 COI. THE CUSTOMER NOTED THAT CONTROLS HAD ALSO BEEN RUNNING HIGHER, WITH SOME NEGATIVE CONTROLS RECOVERING POSITIVE RESULTS. THE AFFECTED PATIENT SAMPLES HAD NEGATIVE ANTI-HBC RESULTS AND THESE VALUES WERE CONSIDERED CORRECT BY THE CUSTOMER. THE NEGATIVE ANTI-HBC VALUES PROMPTED THE CUSTOMER TO QUESTION THE HBIM VALUES. THE HBIM TESTING WAS REPEATED AND THE RESULTS WERE STILL POSITIVE. THE CUSTOMER PROVIDED EXAMPLES OF FOUR PATIENT SAMPLES WITH QUESTIONABLY HIGH HBIM VALUES MEASURED WITH TWO DIFFERENT REAGENT LOTS. THE HBIM LOT NUMBERS WERE 81987901 (EXPIRATION = 31-MAY-2025), 77870501 (EXPIRATION = 31-MAY-2025). PLEASE REFER TO THE ATTACHMENT FOR THE PATIENT DATA. SOME SAMPLES WERE SENT TO ANOTHER LABORATORY FOR TESTING ON THE SIEMENS ADVIA CENTAUR ANALYZER FOR THE HEPATITIS B VIRUS CORE ANTIBODY AND IGM ASSAY. ALL RESULTS OBTAINED WITH THIS COMPETITOR METHOD WERE NEGATIVE. THE SPECIF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20634278 ↗
• MalfunctionOct 10, 2024False Positive Result; Insufficient Device Problem Information; False Positive Result; Insufficient Device Problem Information

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM FOUR PATIENTS TESTED WITH ELECSYS ANTI-HBC IGM AND ELECSYS ANTI-HBC II. THE RESULTS MEASURED BY EACH ASSAY WERE ALLEGED TO BE INCONSISTENT WITH EACH OTHER. THIS MEDWATCH WILL APPLY TO THE ELECSYS ANTI-HBC IGM REAGENT. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS ANTI-HBC II REAGENT. ALL FOUR PATIENTS HAD MULTIPLE SAMPLES DRAWN AT THE SAME TIME. ALL SAMPLES HAD POSITIVE ANTI-HBC IGM RESULTS, BUT NEGATIVE ANTI-HBC RESULTS. NO SPECIFIC DATA WAS PROVIDED. THE PATIENTS' RESULTS WERE REPORTED TO THE MEDICAL DIRECTOR. THE MEDICAL DIRECTOR REVIEWED THE CASES AND REPORTED THE PATIENTS AS NEGATIVE FOR HEPATITIS B BASED ON THE ANTI-HBC RESULTS, PATIENT HISTORY, AND CLINICAL HEALTH OF THE PATIENTS AT THE TIME OF SAMPLE COLLECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20420488 ↗