Elecsys Anti-HAV IIRecalls & reported problems across all models

We found 2 models of Elecsys Anti-HAV II by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Jun 30, 2022 and Jan 27, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys Anti-HAV II problems

Elecsys Anti-HAV II models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys Anti-HAV II 08086664190

  Hepatitis a test (antibody and igm antibody)
  14 reports
• Elecsys Anti-HAV II 08086630190

  Hepatitis a test (antibody and igm antibody)
  13 reports

Recent Elecsys Anti-HAV II adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗

Other Roche Diagnostics GmbH products

• cobas e 411 Immunoassay Analyzer2 models · 1,218 reports
• cobas e 801 Immunoassay analyzer3 models · 713 reports · 1 recall
• CoaguChek XS PT strips2 models · 632 reports
• CoaguChek XS Patient Self Testing Care Kit2 models · 346 reports
• Elecsys FT3 III4 models · 283 reports
• Elecsys Estradiol III2 models · 162 reports
• Elecsys TSH4 models · 155 reports
• Sodium electrode3 models · 150 reports