Elecsys Anti-HAV IgM 07026773190Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04015630939855), received between Apr 25, 2019 and Nov 14, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K093955, K260048); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS ANTI-HAV IGM ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT. THE ELECSYS ANTI-HAV IGM RESULT WAS REACTIVE (1.04 COI). THE CNR RESULT WAS NEGATIVE. THE PCR RESULT WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556192 ↗
• MalfunctionAug 6, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HAV IGM RESULTS FROM THE COBAS E 801 MODULE. THE ANTI-HAV IGM RESULT WAS 2.25 COI (REACTIVE). THE ANTI-HAV G2 RESULT WAS 1.17 COI (NON-REACTIVE). USING A DIFFERENT COBAS INSTRUMENT, THE ANTI-HAV IGM RESULT WAS 2.07 COI (REACTIVE) AND THE ANTI-HAV G2 RESULT WAS 1.15 COI (NON-REACTIVE). THE PATIENT WENT TO ANOTHER LABORATORY, AND THE HAVING RESULT WAS NON-REACTIVE. THE METHOD USED WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726298 ↗
• MalfunctionApr 5, 2024False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS NOT MATCHING THE PATIENTS' CLINICAL DIAGNOSIS FOR 2 PATIENTS WHEN TESTED WITH ELECSYS ANTI-HAV IGM ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 1.09 COI. 1ST REPEAT RESULT: 1.10 COI. 2ND REPEAT RESULT: 1.09 COI (TESTED WITH THE SAME LOT AND DIFFERENT PACK NUMBER). 3RD REPEAT RESULT: 1.06 COI (TESTED WITH THE SAME LOT AND DIFFERENT PACK NUMBER). SAMPLE 2 (PATIENT 2): INITIAL RESULT: 1.50 COI. 1ST REPEAT RESULT: 1.48 COI. 2ND REPEAT RESULT: 1.49 COI (TESTED WITH THE SAME LOT AND DIFFERENT PACK NUMBER). 3RD REPEAT RESULT: 1.50 COI (TESTED WITH THE SAME LOT AND DIFFERENT PACK NUMBER). BOTH SAMPLES' RESULTS WERE INTERPRETED AS FALSE POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053467 ↗
• MalfunctionOct 9, 2023False Positive Result; False Positive Result

  THE INITIAL REPORTER QUESTIONED ONGOING POSITIVE RESULTS FOR 3 PATIENT SAMPLES TESTED FOR ELECSYS ANTI-HAV IGM (ANTI-HAV IGM) ON A COBAS E 801 ANALYTICAL UNIT. THE DATE OF EVENT IS AN APPROXIMATION. ONLY THE YEAR OF TESTING WAS PROVIDED. FOR PATIENT 1: IN 2020, THE PATIENT HAD A RESULT OF 1.2 COI (POSITIVE). IN 2022, THE PATIENT HAD A RESULT OF 1.1 COI (POSITIVE). FOR PATIENT 2: IN 2020, THE PATIENT HAD A RESULT OF 1.7 COI (POSITIVE). IN 2022, THE PATIENT HAD A RESULT OF 1.5 COI (POSITIVE). IN 2023, THE PATIENT HAD A RESULT OF 1.7 COI (POSITIVE). ON (B)(6) 2023 THE SAMPLE WAS REPEATED WITH A RESULT OF 1.49 COI (POSITIVE). FOR PATIENT 3: IN 2021, THE PATIENT HAD A RESULT OF 2.9 COI (POSITIVE). IN 2022, THE PATIENT HAD A RESULT OF 3.5 COI (POSITIVE). IN 2023, THE PATIENT HAD A RESULT OF 3.0 COI (POSITIVE). A SAMPLE FROM PATIENT 3 WAS ALSO SENT FOR TESTING BY THE ALINITY METHOD AND THE RESULT WAS POSITIVE. THE SPECIFIC RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17896501 ↗
• MalfunctionJun 1, 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 IGM. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ELECSYS ANTI-HAV 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 17043521 ↗
• MalfunctionApr 17, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-HAV IGM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARE TO AN ABBOTT CMIA ANALYZER. ON (B)(6) 2023, THE ELECSYS ANTI-HAV IGM RESULT WAS 1.20 COI, INTERPRETED AS REACTIVE. ON (B)(6) 2023, THE ABBOTT ANTI-HAV IGM RESULT WAS 0.6 COI, INTERPRETED AS NON-REACTIVE. ON (B)(6) 2023, AN ALIQUOT OF THE ORIGINAL SAMPLE WAS REPEATED ON THE E801 ANALYZER AGAIN TWICE. THE RESULTS WERE 1.23 COI AND 1.17 COI, BOTH INTERPRETED AS REACTIVE. THE INITIAL REACTIVE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE NON-REACTIVE RESULT WAS DEEMED CORRECT. THE ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755835 ↗
• MalfunctionNov 17, 2021False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF POTENTIALLY (B)(6) RESULTS FOR TWO PATIENTS TESTED ON A COBAS E 801 ANALYTICAL UNIT WITH SERIAL (B)(4). THE INITIAL REPORTER EXPRESSED CONCERN REGARDING (B)(6) RESULTS OBTAINED FOR PATIENTS WITH (B)(6). THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THE REPORTER WAS ABLE TO PROVIDE TWO EXAMPLES OF QUESTIONABLE RESULTS. THE SPECIMEN FROM PATIENT 1 WAS RERUN ON AN ABBOTT ANALYZER. THE SPECIMEN FROM PATIENT 2 WAS RERUN ON AN ABBOTT AND A SIEMENS ANALYZER. PLEASE REFER TO THE ATTACHMENT ON THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827568 ↗
• MalfunctionSep 23, 2021False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE FALSE-POSITIVE ANTI-HAV IGM ELECSYS RESULT FROM COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 1.78 COI (POSITIVE). THE REPEAT RESULT WAS 1.75 COI (POSITIVE). THE REPEAT RESULT AFTER CENTRIFUGATION WITH A HIGH-SPEED CENTRIFUGE WAS 1.71 COI (POSITIVE). THE RESULT FROM A SIEMENS ANALYZER WAS 0.10 COI (NEGATIVE). THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519814 ↗
• MalfunctionApr 25, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS HIGH RESULTS WERE GENERATED BY A COBAS E801 MODULE. THE EVENT INVOLVED 1 PATIENT WITH THE HIGH RESULTS FOR ANTI-HAV IGM. THE PATIENT WAS A MALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8551514 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093955, K260048. One submission often covers many models, so check the product and lot details in each record.

• Z-0669-2020 · Oct 28, 2019 · Terminated
  Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
• Z-0784-2019 · Dec 17, 2018 · Terminated
  Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to