Elecsys Anti-HAV II 08086630190Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613336129722), received between Jun 30, 2022 and May 6, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HAV II RESULTS FOR 2 PATIENTS ON A COBAS E 411 ANALYZER (RACK SYSTEM). PATIENT 1: THE INITIAL RESULT WAS 0.976 COI (REACTIVE). THE CONFIRMATION RESULTS FOR THE SAMPLE (USING THE ABBOTT ARCHITECT METHOD) WERE NONREACTIVE. THE ANTI-HAV IGM RESULT WAS 0.10, AND THE ANTI-HAV IGG RESULT WAS 0.12. THE UNITS OF MEASURE FOR THE CONFIRMATION RESULTS WERE NOT PROVIDED. PATIENT 2: THE REPORTER STATED THAT THE PATIENT'S SAMPLES WERE REPEATEDLY REACTIVE. ON (B)(6) 2024, THE PATIENT'S RESULT WAS 0.966 COI (REACTIVE). ON (B)(6) 2025, A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 0.955 COI (REACTIVE). THE CONFIRMATION RESULTS FOR THE (B)(6) 2025 SAMPLE (USING THE ABBOTT ARCHITECT METHOD) WERE NONREACTIVE. THE ANTI-HAV IGM RESULT WAS 0.09, AND THE ANTI-HAV IGG RESULT WAS 0.28. THE UNITS OF MEASURE FOR THE CONFIRMATION RESULTS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21970651 ↗
• MalfunctionMay 2, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS ANTI-HAV II RESULT FROM THE COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL ANTI-HAV TOTAL RESULT OF 0.918 COI WAS REACTIVE, AND THE ANTI-HAV IGM RESULT OF 0.224 COI WAS NON-REACTIVE. THE CUSTOMER RECEIVED CONFIRMATION FROM ANOTHER INSTITUTE WITH A RESULT FOR ANTI-HAV IGG OF 0.16 COI AND ANTI-HAV IGM RESULT OF 0.08 WERE BOTH NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950106 ↗
• MalfunctionDec 22, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ANTI-HAV G2 ELECSYS RESULTS FROM THE COBAS 6000 E601 MODULE. THE RESULTS FROM THE COBAS E601 WERE 0.96 AND 0.97 COI (REACTIVE). THE RESULT FROM AN ABBOTT ANALYZER WAS NEGATIVE WHICH WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18381454 ↗
• MalfunctionDec 14, 2023False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE POSITIVE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ELECSYS ANTI-HAV II ON A COBAS 6000 E601 MODULE. A DOCTOR COMPLAINED THAT THE RESULTS DID NOT AGREE WITH THE CLINICAL STATUS OF THE PATIENTS. THE PATIENTS DID NOT RECEIVE VACCINATION FOR HEPATITIS A AND ALSO HAD NO KNOWN HEPATITIS A INFECTION. THE CUSTOMER STATED PATIENT SAMPLES WILL RECOVER ANTI-HAV VALUES OF 0.96 COI (REACTIVE), 0.97 COI (REACTIVE), OR 0.99 COI (REACTIVE) FOR EXAMPLE. THESE SAMPLES WERE REPEATED AND THE VALUES WERE STILL POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327177 ↗
• MalfunctionOct 16, 2023False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS ANTI-HAV II (ANTI-HAV G2) ASSAY ON A COBAS 6000 E601 IMMUNOASSAY ANALYZER. INITIAL RESULT: 0.782 COI. 1ST RERUN RESULT: 0.764 COI. SINCE THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL HISTORY, THE CUSTOMER PERFORMED A LIQUID FLOW CLEANING ON THE INSTRUMENT, RE-CALIBRATED, AND RERAN QC. THE PATIENT'S SAMPLE WAS THEN RERUN. 2ND RERUN RESULT: 1.18 COI. THE 2ND RERUN RESULT WAS DEEMED TO BE CORRECT AS IT MATCHED THE PATIENT'S CLINICAL PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939730 ↗
• MalfunctionSep 12, 2023Insufficient Device Problem Information; Non Reproducible Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS ANTI-HAV II ON A COBAS 6000 E601 MODULE. THE FIRST SAMPLE INITIALLY RESULTED IN A NEGATIVE ANTI-HAV VALUE (LESS THAN 20 IU/L). THE SAMPLE WAS REPEATED AFTER RE-CALIBRATION, RESULTING IN A VALUE OF 0F 0.935 COI (REACTIVE). THE SECOND SAMPLE INITIALLY RESULTED IN A POSITIVE ANTI-HAV VALUE (GREATER THAN 20 IU/L) ON (B)(6) 2023. THE SAMPLE WAS REPEATED AFTER RE-CALIBRATION, RESULTING IN A VALUE OF 1.01 COI (NON-REACTIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731627 ↗
• MalfunctionAug 14, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ANTI-HAV II RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS COMPARED WITH THE ANTI-HAV IGM RESULT FROM THE MODULE AND THE ANTI-HAV IGG RESULT FROM THE ARCHITECT I1000SR ANALYZER. THE ANTI-HAV II RESULT FROM THE MODULE WAS "REACTIVE". THE ANTI-HAV IGM RESULT FROM THE MODULE WAS "NON-REACTIVE". THE ANTI-HAV IGG RESULT FROM ARCHITECT I1000SR WAS "NON-REACTIVE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17545724 ↗
• MalfunctionJul 6, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HAV GEN.2 ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE PATIENT HAD AN INITIAL ANTI-HAV RESULT OF 0.827 COI, INTERPRETED AS REACTIVE. THE PATIENT SAMPLE WAS TESTING USING ANOTHER METHOD AND THE RESULT WAS NON-REACTIVE. THE OTHER TESTING METHOD USED WAS NOT PROVIDED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270337 ↗
• MalfunctionJun 16, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR "SEVERAL" PATIENT SAMPLES TESTED FOR ELECSYS ANTI-HAV II (ANTI-HAV II) USING REAGENT LOT 625986 ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE REPORTER ALSO QUESTIONED RESULTS CLOSE TO THE CUT-OFF WITH NEW REAGENT LOT 695556. ON (B)(6) 2023 SAMPLE ID (B)(6) RESULT WITH REAGENT LOT 625986 WAS 1.00 COI (POSITIVE). ON (B)(6) 2023 THE RESULT WITH REAGENT LOT 695556 WAS 1.17 COI (NEGATIVE). ON (B)(6) 2023 SAMPLE ID (B)(6) RESULT WITH REAGENT LOT 625986 WAS 0.89 COI (POSITIVE). ON (B)(6) 2023 THE RESULT WITH REAGENT LOT 695556 WAS 1.03 COI (NEGATIVE). ON (B)(6) 2023 SAMPLE ID (B)(6) RESULT WITH REAGENT LOT 625986 WAS 0.95 COI (POSITIVE). ON (B)(6) 2023 THE RESULT WITH REAGENT LOT 695556 WAS 1.21 COI (NEGATIVE). ON (B)(6)2023 SAMPLE ID (B)(6) RESULT WITH REAGENT LOT 625986 WAS 0.87 COI (POSITIVE). ON (B)(6) 2023 THE RESULT WITH REAGENT LOT 695556 WAS 1.01 COI (NEGATIVE). THE POSITIVE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED BY THE PHYSICIAN. THE PATIENTS DID NOT RECEIVE VACCINATION AND ARE NOT KNOWN TO HAVE A HEPATITIS A INFECTION. ON (B)(6) 2023 SAMPLES FROM EMPLOYEES AT THE CUSTOMER SITE WERE TESTED FOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145126 ↗
• MalfunctionMay 1, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE POSITIVE ANTI-HAV G2 ELECSYS RESULTS FROM COBAS 6000 E601 MODULE SERIAL NUMBER (B)(6) COMPARED TO THE ABBOTT ASSAY. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. IT WAS REQUESTED BUT NOT KNOWN IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16847770 ↗
• MalfunctionApr 7, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS ANTI-HAV II ASSAY ON A COBAS 6000 CORE UNIT, SERIAL NUMBER (B)(4). PATIENT SAMPLE 1: ON (B)(6) 2023, THE SAMPLE HAD AN ANTI-HAV II RESULT OF 0.867 (REACTIVE). THE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. AT AN UNKNOWN DATE, THE SAMPLE WAS MEASURED WITH THE ARCHITECT I1000SR METHOD, RESULTING IN A NON-REACTIVE ANTI-HAV IGG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700324 ↗
• MalfunctionMar 13, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ANTI-HAV G2 RESULTS FROM COBAS E411 RACK ANALYZER SERIAL NUMBER (B)(4). DATA WAS PROVIDED FOR ONE PATIENT WHO WAS PRESUMED NOT TO BE INFECTED WITH TYPE A. IN (B)(6) 2023, THE RESULT FROM THE ABBOTT ALINITY WAS 0.32. ON (B)(6) 2023, THE RESULT FROM THE COBAS E411 WAS 0.438 COI (POSITIVE). ON (B)(6) 2023, THE RESULT FROM A SIEMENS CENTAUR WAS NEGATIVE. ON (B)(6) 2023, THE RESULT FROM THE COBAS E411 WAS 0.45 COI (POSITIVE). ON (B)(6) 2023, THE RESULT FROM A COBAS E801 WAS 0.427 COI (POSITIVE). THE SAME WAS REPEATED NUMEROUS TIMES ON THE E411 WITH RESULTS OF 1.02, 0.947, 1.06, 1.09 COI (NON-REACTIVE). ON AN E801 ON ANOTHER LABORATORY, THE RESULT WAS 1.17 COI (NON-REACTIVE). ON AN ABBOTT ALINITY, THE RESULT WERE 0.24 AND 0.11 (NON-REACTIVE). IT WAS REQUESTED BUT WAS UNKNOWN IF ANY QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528953 ↗
• MalfunctionJun 30, 2022False Positive Result; False Positive Result

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS ANTI-HAV II (ANTI-HAV II) BETWEEN (B)(6) 2022 AND (B)(6) 2022 ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE FOLLOWING ARE EXAMPLES OF POSITIVE RESULTS FOR 5 PATIENT SAMPLES: (B)(6). THE CUSTOMER REPEATED THE SAMPLES ON THE SAME ANALYZER AND OBTAINED THE SAME POSITIVE RESULTS. THE CUSTOMER HAS NOT REPEATED THE SAMPLES BY ANOTHER METHOD. THE CUSTOMER ALLEGES THE RESULTS FOR THESE PATIENTS ARE "FALSE" POSITIVE. CLARIFICATION HAS BEEN REQUESTED AS TO WHY THE POSITIVE RESULTS ARE IN QUESTION, HOWEVER, CLARIFICATION HAS NOT BEEN RECEIVED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E411 ANALYZER SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876034 ↗