cobas e 411 Immunoassay AnalyzerRecalls & reported problems across all models

We found 2 models of cobas e 411 Immunoassay Analyzer by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 1,218 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2018 and Sep 30, 2026 — classified as 4 injuries, 1,214 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (652 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 cobas e 411 Immunoassay Analyzer problems

cobas e 411 Immunoassay Analyzer models

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

• cobas e 411 Immunoassay Analyzer 04775201001

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  685 reports
• cobas e 411 Immunoassay Analyzer 04775279001

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  533 reports

Recent cobas e 411 Immunoassay Analyzer adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947527 ↗
• MalfunctionSep 29, 2026High Test Results; Non Reproducible Results

  There was an allegation of questionable Elecsys Estradiol III Assay results for 2 patient samples on a cobas e 411 analyzer (disk system). Patient 1's initial result was 680.8 pg/mL.The repeat results were 51.72 pg/mL and 61.05 pg/mL.Patient 2's initial result on 09-Sep-2026 was 166.7 pg/mL.The repeat result was 52.57 pg/mL. The repeat results were deemed to be correct, as the initial high results did not match clinical expectations.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931704 ↗
• MalfunctionSep 28, 2026Non Reproducible Results

  There was an allegation of questionable Elecsys Estradiol III Assay results for 1 patient sample on a cobas e 411 analyzer (rack system).The initial result was >3000 pg/mL with a data flag.Because the result had a data flag, the sample was repeated with a (1:10) dilution, and the result was 275.4 pg/mL.The sample was repeated without dilution, and the results were 37.32 pg/mL, 22.74 pg/mL, and 21.43 pg/mL.The result of 21.43 pg/mL was believed to be correct.The results of 22.74 pg/mL and 21.43 pg/mL were obtained using a different reagent pack.The questionable results were not reported outside the laboratory.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914898 ↗
• MalfunctionSep 25, 2026False Positive Result

  There was an allegation of questionable results for multiple assays from the cobas e411 rack analyzer. The samples were repeated on a cobas e 402 analyzer.For the Anti-HAV IgM assay, the Elecsys HBsAg II assay, and the Elecsys HIV combi PT assay, the results were allegedly false positives. No specific data was provided.The questionable results were not reported outside of the laboratory.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900103 ↗
• MalfunctionSep 25, 2026High Test Results; Low Test Results; Non Reproducible Results

  The initial reporter received questionable Elecsys HCG STAT and Elecsys Troponin T hs STAT assay results for multiple patient samples tested on the cobas e 411 analyzer (disk system).The following patient samples with discrepant results were provided:Patient Sample 1HCG Initial analysis of the patient sample yielded <1 mIU/mL.Repeat analysis yielded 542 and 534 mIU/mL.Patient Sample 2Troponin T hs Initial analysis of the patient sample yielded 22 ng/L.Repeat analysis yielded 9 ng/L.Patient Sample 3Troponin T hs Initial analysis of the patient sample yielded 25 ng/L.Repeat analysis yielded 6 ng/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899601 ↗
• MalfunctionSep 24, 2026Incorrect Measurement

  There was an allegation of a questionable Elecsys HCG+¿ result for 1 patient sample on a cobas e 411 analyzer (rack system). The initial result was 0.258 mIU/mL. The repeat result was 28,000 mIU/mL.The sample was repeated after the patient questioned the initial result. The repeat result is deemed to be correct as it corresponds to the patient's clinical picture.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883304 ↗
• MalfunctionSep 23, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871473 ↗
• MalfunctionSep 18, 2026High Test Results; Non Reproducible Results

  The initial reporter received questionable Elecsys Estradiol III Assay results for two patient samples tested on the cobas e 411 analyzer (disk system).Sample 1: Initial analysis yielded a result of 815.9 pg/mL.Repeat analysis yielded a result of <5 pg/mL.Sample 2: Initial analysis yielded a result of >3000 pg/mL with a data flag.Repeat analysis yielded a result of <5 pg/mL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817046 ↗
• MalfunctionSep 10, 2026High Test Results; Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721073 ↗
• MalfunctionAug 21, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50375921 ↗
• MalfunctionAug 20, 2026Low Test Results; Output Problem; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50345900 ↗
• MalfunctionAug 17, 2026Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287742 ↗
• MalfunctionAug 17, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286348 ↗
• MalfunctionJun 3, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS TOTAL PSA RESULT FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (RACK SYSTEM) MODULE. THE INITIAL RESULT WAS 0.695 NG/ML. THE REPEAT RESULTS ON (B)(6) 2026 WERE BOTH 0.006 NG/ML, ACCOMPANIED BY DATA FLAGS. THE PATIENT COMPLAINED ABOUT THE INITIAL RESULT WHEN THEY GOT A DIFFERENT RESULT FROM ANOTHER LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25377970 ↗
• MalfunctionMay 27, 2026Suction Problem; High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULT FROM THE COBAS E 411 ANALYZER (DISK SYSTEM) FOR 1 PATIENT. THE INITIAL RESULT ON (B)(6) 2026 WAS 808.8 PG/ML. THE PATIENT RETURNED FOR REPEAT TESTING ON (B)(6) 2026, AND THE NEW RESULT WAS SIGNIFICANTLY LOWER; THE EXACT RESULT WAS NOT AVAILABLE. THE INITIAL SAMPLE WAS RETESTED BECAUSE OF THE DIFFERENCE IN RESULTS. THE REPEAT RESULT ON (B)(6) 2026 WAS 23.77 PG/ML. DURING AN ON-SITE INVESTIGATION, THE SAMPLE WAS REPEATED AGAIN, AND THE RESULT WAS 30.47 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305387 ↗

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