Elecsys Anti-HAV II 08086664190Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613336129715), received between Dec 8, 2022 and Jan 27, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026False Negative Result; Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE NON-REACTIVE RESULTS FOR SIX PATIENT SAMPLES TESTED WITH ELECSYS ANTI-HAV II ON A COBAS E 801 ANALYTICAL UNIT. PREVIOUS SAMPLES FROM THESE PATIENTS HAD REACTIVE RESULTS. THE FIRST PATIENT SAMPLE RESULTED IN ANTI-HAV VALUES OF 1.02 IU/L (NON-REACTIVE), 1.02 IU/L (NON-REACTIVE), AND 1.02 IU/L (NON-REACTIVE). THE SECOND PATIENT SAMPLE RESULTED IN ANTI-HAV VALUES OF 1.04 IU/L (NON-REACTIVE), 1.04 IU/L (NON-REACTIVE), AND 1.04 IU/L (NON-REACTIVE). THE THIRD PATIENT SAMPLE RESULTED IN ANTI-HAV VALUES OF 1.20 IU/L (NON-REACTIVE), 1.19 IU/L (NON-REACTIVE), AND 1.20 IU/L (NON-REACTIVE) ON (B)(6) 2025. THE FOURTH PATIENT SAMPLE RESULTED IN ANTI-HAV VALUES OF 1.07 IU/L (NON-REACTIVE), 1.04 IU/L (NON-REACTIVE), AND 1.04 (NON-REACTIVE) ON (B)(6) 2025. THE FIFTH PATIENT SAMPLE RESULTED IN ANTI-HAV VALUES OF 1.10 IU/L (NON-REACTIVE) AND 1.10 IU/L (NON-REACTIVE) ON (B)(6) 2025. THE SIXTH PATIENT SAMPLE RESULTED IN ANTI-HAV VALUES OF 1.06 IU/L (NON-REACTIVE) AND 1.07 IU/L (NON-REACTIVE) ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191138 ↗
• MalfunctionNov 5, 2025False Positive Result; Output Problem; False Positive Result; Output Problem

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE HIGH RESULTS FOR 13 PATIENTS' SAMPLES TESTED WITH ELECSYS ANTI-HAV II ASSAY ON A COBAS E 801 MODULE WHEN COMPARED TO THE COMPETITOR'S METHOD. INITIAL RESULTS: REACTIVE. REPEAT RESULTS: NON-REACTIVE. THE CUSTOMER OBSERVED AN INCREASED NUMBER OF A-HAV II RESULTS IN THE RANGE OF 0.6 COI TO 0.99 COI, WHICH WERE ALSO DISCREPANT WHEN COMPARED TO THE COMPETITOR'S RESULTS. THREE OTHER SAMPLES SHOWED BORDERLINE NEGATIVE VALUES OF 1.01 COI, 1.02 COI, AND 1.02 COI UPON RE-MEASUREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478680 ↗
• MalfunctionApr 22, 2025False Positive Result; Output Problem; False Positive Result; Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR EIGHTEEN PATIENT SAMPLES TESTED WITH ELECSYS ANTI-HAV II ON AN UNKNOWN ROCHE ANALYZER. THE CUSTOMER STATES THE REACTIVE RESULTS OBTAINED WITH THE ROCHE ANTI-HAV METHOD ARE NOT CONSISTENT WITH COMPETITOR ANTI-HAV IGG AND ANTI-HAV IGM RESULTS. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885375 ↗
• MalfunctionOct 3, 2024False Negative Result; False Positive Result; Incorrect Measurement; False Negative Result; False Positive Result; Incorrect Measurement

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-HAV II (ANTI-HAV II) RESULTS FROM FIVE PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. SAMPLE 1 ON (B)(6) 2024: THE INITIAL RESULT FROM THE ANALYZER WAS 0.988 CUT-OFF INDEX COI (REACTIVE) ON (B)(6) 2024: THE REPEAT RESULT FROM ANOTHER E801 ANALYZER WAS 1.02 COI (NON-REACTIVE). SAMPLE 2 ON (B)(6) 2024: THE INITIAL RESULT FROM THE ANALYZER WAS 0.943 COI (REACTIVE) ON (B)(6) 2024: THE REPEAT RESULT FROM ANOTHER E801 ANALYZER WAS 1.01 COI (NON-REACTIVE). THE REPEAT RESULT FROM THE ANALYZER WAS 0.985 COI (REACTIVE). SAMPLE 3 ON (B)(6) 2024: THE INITIAL RESULT WAS 0.611 COI (REACTIVE) ON (B)(6) 2024: THE REPEAT RESULT WAS 1.05 COI (NON-REACTIVE). SAMPLE 4 ON (B)(6) 2024: THE INITIAL RESULT FROM THE ANALYZER WAS 0.966 COI (REACTIVE) ON (B)(6) 2024: THE REPEAT RESULT FROM ANOTHER E801 ANALYZER WAS 1.05 COI (NON-REACTIVE). THE REPEAT RESULT FROM THE ANALYZER WAS 1.00 COI (REACTIVE). SAMPLE 5 ON (B)(6) 2024: THE INITIAL RESULT FROM THE ANALYZER WAS 0.993 COI (REACTIVE). THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 0.984 COI (REACTIVE). THE SECOND REPEAT RESULT FROM THE OTHER E801 ANALYZER WAS 1.05 COI (NON-REACTIVE). THE THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362347 ↗
• MalfunctionJan 10, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE POSITIVE RESULTS FOR 1 PATIENT'S SERUM/PLASMA SAMPLE TESTED WITH ELECSYS ANTI-HAV G2 (ANTI-HAV II) ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER. ON (B)(6) 2023: INITIAL RESULT: 0.674 COI (POSITIVE). ON (B)(6) 2023, A NEW SAMPLE WAS DRAWN AND TESTED. RESULT: 1.020 COI (NEGATIVE). RERUN RESULT: 1.060 COI (NEGATIVE). THE RESULTS WERE NOT CONSISTENT WITH THE PATIENT'S PREVIOUS RESULTS. THE REPEAT RESULT OF THE ORIGINAL SAMPLE FROM (B)(6) 2023 WAS 1.030 COI (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18485661 ↗
• MalfunctionNov 29, 2023False Positive Result; Optical Problem; Output Problem; False Positive Result; Optical Problem; Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR FIFTEEN PATIENT SAMPLES TESTED WITH ELECSYS ANTI-HAV II ON AN UNKNOWN ROCHE ANALYZER. THE CUSTOMER STATES THE POSITIVE RESULTS OBTAINED WITH THE ROCHE ANTI-HAV METHOD ARE NOT CONSISTENT WITH COMPETITOR ANTI-HAV IGG RESULTS. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18228625 ↗
• MalfunctionJul 20, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 15 PATIENT SAMPLES TESTED FOR ELECSYS ANTI-HAV II (ANTI-HAV II) BETWEEN DIFFERENT REAGENT LOTS ON A COBAS E 801 ANALYTICAL UNIT. PATIENTS WHO PREVIOUSLY HAD REACTIVE RESULTS ARE NOW NON-REACTIVE. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362981 ↗
• MalfunctionJun 2, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HAV ASSAY AND ELECSYS ANTI-HAV IGM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER ELECSYS ANTI-HAV. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ELECSYS ANTI-HAV IGM RESULTS. THE INITIAL ANTI-HAV RESULT WAS 0.21 COI, INTERPRETED AS POSITIVE. THE INITIAL ANTI-HAV IGM WAS 7.44 COI, INTERPRETED AS POSITIVE. THE DATES OF TESTING WERE REQUESTED BUT NOT PROVIDED. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT FOR ELISA TESTING. ON (B)(6) 2023, THE ANTI-HAV IGM ELISA RESULT WAS NEGATIVE. ON (B)(6) 2023, THE ANTI-HAV ELISA RESULT WAS NEGATIVE. THE MANUFACTURER OF THE ELISA TESTS WAS NOT PROVIDED. THE ANALYZER SERIAL NUMBER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17046151 ↗
• MalfunctionMay 23, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HAV ASSAY RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2023, THE ANTI-HAV RESULT WAS 1.050 COI, INTERPRETED AS NEGATIVE, AND AN A-HAV IGM RESULT OF 0.284 COI, INTERPRETED AS NEGATIVE. THE SAMPLE WAS REPEATED AND THE REPEAT ANTI-HAV RESULT WAS 1.11 COI. ON (B)(6) 2023, THE ANTI-HAV RESULT WAS 0.781 COI, INTERPRETED AS POSITIVE, AND AN A-HAV IGM RESULT OF 0.358 COI, INTERPRETED AS NEGATIVE. THE SAMPLE WAS REPEATED AND THE REPEAT ANTI-HAV RESULT WAS 0.84 COI. ON (B)(6) 2023, THE ANTI-HAV RESULT WAS 0.979 COI, INTERPRETED AS POSITIVE, AND AN A-HAV IGM RESULT OF 0.411 COI, INTERPRETED AS NEGATIVE. IT IS UNKNOWN IF ANY QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16987492 ↗
• MalfunctionApr 20, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR 8 PATIENT SAMPLES TESTED WITH THE ELECSYS ANTI-HAV II ON A COBAS E 801 ANALYTICAL UNIT, SERIAL NUMBER (B)(6). THE SAMPLES WERE DISCREPANT POSITIVE WHEN COMPARED TO THE NEGATIVE ANTI-HAV RESULTS OBTAINED IN A DIFFERENT LABORATORY BY USING A COMPETITOR METHOD FROM ABBOTT. PATIENT 1 (SAMPLE FROM (B)(6) 2023) HAD AN ANTI-HAV II RESULT OF(B)(6). PATIENT 2 (SAMPLE FROM (B)(6) 2023) HAD AN ANTI-HAV II RESULT OF (B)(6). PATIENT 3 (SAMPLE FROM (B)(6) 2023) HAD AN ANTI-HAV II RESULT OF (B)(6). PATIENT 4 (SAMPLE FROM (B)(6) 2023) HAD AN ANTI-HAV II RESULT OF (B)(6). PATIENT 5 (SAMPLE FROM (B)(6) 2023) HAD AN ANTI-HAV II RESULT OF (B)(6). PATIENT 6 (SAMPLE FROM (B)(6) 2023) HAD AN ANTI-HAV II RESULT OF (B)(6). PATIENT 7 (SAMPLE FROM (B)(6) 2022) HAD AN ANTI-HAV II RESULT OF (B)(6). PATIENT 8 (SAMPLE FROM (B)(6) 2023) HAD AN ANTI-HAV II RESULT OF (B)(6). THE POSITIVE ANTI-HAV II RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16780964 ↗
• MalfunctionFeb 3, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF FALSE POSITIVE RESULTS FOR 2 PATIENTS TESTED FOR ELECSYS ANTI-HAV II (ANTI-HAV II) ON A COBAS E 801 MODULE. ON (B)(6) 2022 PATIENT 1 HAD AN ANTI-HAV II RESULT OF 0.995 COI (POSITIVE). ON (B)(6) 2023 A SERUM SAMPLE AND A LITHIUM-HEPARIN SAMPLE WERE OBTAINED. THE RESULTS FROM THE SERUM SAMPLE WERE 1.04 COI (NEGATIVE), 1.05 COI (NEGATIVE), AND 1.06 COI (NEGATIVE). THE RESULTS FROM THE LITHIUM-HEPARIN SAMPLE WERE 1.01 COI (NEGATIVE), 1.00 COI (NEGATIVE), AND 0.993 COI (POSITIVE). ON (B)(6) 2023 TWO LITHIUM-HEPARIN SAMPLES WERE OBTAINED FOR PATIENT 2. FROM SAMPLE ID (B)(6) THE RESULTS WERE 1.00 COI (NEGATIVE), 0.992 COI (POSITIVE), AND 1.00 COI (POSITIVE). FROM SAMPLE ID (B)(6) THE RESULTS WERE 0.998 COI (POSITIVE), 0.993 COI (POSITIVE), AND 1.01 COI (NEGATIVE). THERE WAS NO CENTRIFUGATION STEP BETWEEN THE RESULTS. ALL RESULTS WERE FROM THE PRIMARY SAMPLE TUBE. THE E801 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16296064 ↗
• MalfunctionJan 9, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH THE ELECSYS ANTI-HAV II ON A COBAS E 801 ANALYTICAL UNIT, SERIAL NUMBER 1983-05. THE POSITIVE RESULTS DID NOT FIT THE CLINICAL HISTORY OF THE PATIENTS AS NO VACCINATION OR INFECTION IS KNOWN/ASSUMED. PATIENT 1: THE SAMPLE INITIALLY RESULTED IN AN ANTI-HAV II VALUE OF 1.0 COI. A SECOND SAMPLE DRAWN FROM THE SAME PATIENT RESULTED IN AN ANTI-HAV II VALUE OF 1.0 COI. THE SAMPLE WAS THEN REPEATED IN A DIFFERENT LABORATORY BY USING AN IMMUNOLUMINOMETRIC ASSAY (ILMA) METHOD, SHOWING A NEGATIVE RESULT. PATIENT 2: THE SAMPLE INITIALLY RESULTED IN AN ANTI-HAV II VALUE OF 0.7 COI. A SECOND SAMPLE DRAWN FROM THE SAME PATIENT RESULTED IN AN ANTI-HAV II VALUE OF 0.71 COI. THE SAMPLE WAS THEN REPEATED IN A DIFFERENT LABORATORY BY USING AN IMMUNOLUMINOMETRIC ASSAY (ILMA) METHOD, SHOWING A POSITIVE RESULT. PATIENT 3: THE SAMPLE INITIALLY RESULTED IN AN ANTI-HAV II VALUE OF 0.85 COI. A SECOND SAMPLE DRAWN FROM THE SAME PATIENT RESULTED IN AN ANTI-HAV II VALUE OF 0.857 COI. THE SAMPLE WAS THEN REPEATED IN A DIFFERENT LABORATORY BY USING AN IMMUNOLUMINOMETRIC (ILMA) ASSAY METHOD, SHOWING A NEGATIVE RESU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122481 ↗
• MalfunctionDec 27, 2022False Positive Result; Non Reproducible Results; False Positive Result; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HAV ASSAY GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL ANTI-HAV RESULT WAS 0.790 COI, INTERPRETED AS REACTIVE. THE SAMPLE WAS RECENTRIFUGED AND REPEATED. THE REPEAT RESULT WAS 1.19 COI, INTERPRETED AS NON-REACTIVE. THE NEXT DAY, THE SAMPLE WAS RECENTRIFUGED AGAIN AND REPEATED AGAIN. THE SECOND REPEAT RESULT WAS 1.19 COI, INTERPRETED AS NON-REACTIVE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT IS 625717 AND THE EXPIRATION DATE IS 31-JUL-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16053240 ↗
• MalfunctionDec 8, 2022False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HAV II ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2022, THE PATIENT HAD ANTI-HAV QUALITATIVE RESULT OF 0.008 C.O.I., INTERPRETED AS POSITIVE. ON (B)(6) 2022 , THE SAMPLE WAS RE-CENTRIFUGED AND REPEATED. THE REPEAT ANTI-HAV QUALITATIVE RESULT WAS 0.00777 C.O.I., INTERPRETED AS POSITIVE. AN ANTI-HAV IGM TEST WAS ALSO PERFORMED ON THE SAMPLE AND THE RESULT WAS 0.342 C.O.I., INTERPRETED AS NEGATIVE. THE SAMPLE WAS SENT TO ANOTHER LAB FOR ELISA TESTING. THE ANTI-HAV IGG AND ANTI-HAV IGM RESULTS WERE BOTH NEGATIVE. IT WAS CONFIRMED THAT THE PATIENT HAD NOT RECENTLY RECEIVED A HEPATITIS A VACCINE. THE POSITIVE ANTI-HAV RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15945121 ↗