Elecsys InsulinRecalls & reported problems across all models

We found 2 models of Elecsys Insulin by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2018 and Sep 24, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “High Test Results” (17 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 Insulin problems

Elecsys Insulin models

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

• Elecsys Insulin 07027559190

  RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN
  18 reports
• Elecsys Insulin 12017547122

  RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN
  12 reports

Recent Elecsys Insulin adverse event reports

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

• MalfunctionSep 24, 2026High Test Results; Low Test Results; Output Problem; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882712 ↗
• MalfunctionSep 21, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847318 ↗
• MalfunctionOct 29, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS INSULIN RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO AN ABBOTT ALINITY ANALYZER. THE E801 RESULT WAS 0.4 UIU/ML. THE DOCTOR QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL STATUS. THE SAMPLE WAS REPEATED ON THE ALINITY ANALYZER AND THE RESULT WAS 20 UIU/ML. THE SAMPLE WAS REPEATED AGAIN ON ANOTHER E801 ANALYZER AND THE RESULT WAS 0.2 UIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416804 ↗
• MalfunctionOct 23, 2025Incorrect Measurement; Low Test Results; Non Reproducible Results; Incorrect Measurement; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS INSULIN RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 MODULE. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE C-PEPTIDE RESULTS. ON (B)(6) 2025, SAMPLE 1 HAD AN INITIAL RESULT OF <3 PMOL/L. THE REPEAT RESULT WAS 34 PMOL/L. ON (B)(6) 2025, SAMPLE 2 HAD AN INITIAL RESULT OF <3 PMOL/L. THE REPEAT RESULT WAS 50 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368632 ↗
• MalfunctionJun 12, 2025Incorrect Measurement; Low Test Results; Compatibility Problem; Incorrect Measurement; Low Test Results; Compatibility Problem

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS < 0.4 UU/ML. THE REPEAT RESULT FROM A COMPETITOR METHOD WAS 26.6 MIU/L PATIENT 2 INITIAL RESULT WAS < 0.4 UU/ML. THE REPEAT RESULT FROM A COMPETITOR METHOD WAS 67.2 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194073 ↗
• MalfunctionMay 8, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS 8000 CORE UNIT. PATIENT 1 INITIAL RESULT WAS 3.94 PMOL/L. THE REPEAT RESULT WAS 401 PMOL/L. PATIENT 2 INITIAL RESULT WAS 39.5 PMOL/L. THE REPEAT RESULT WAS 1383 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986496 ↗
• MalfunctionApr 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS INSULIN RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 3.66 MIU/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 1.66 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900556 ↗
• MalfunctionOct 18, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS INSULIN RESULTS FOR 6 PATIENT SAMPLES ON A COBAS 8000 - COBAS E 602 MODULE. THE CUSTOMER QUESTIONED THE LOW INITIAL RESULTS WHICH PROMPTED THEM TO REPEAT THE PATIENT SAMPLES. ON (B)(6) 2024, SAMPLE 1 HAD AN INITIAL INSULIN RESULT OF 16.66 UU/ML. THE SAMPLE WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS 21.1 UU/ML. ON (B)(6) 2024, SAMPLE 2 HAD AN INITIAL INSULIN RESULT OF 7.10 UU/ML. THE SAMPLE WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS 14.1 UU/ML. ON (B)(6) 2024, THE SAMPLE WAS REPEATED ON THE INITIAL E602 ANALYZER AND THE RESULT WAS 14.88 UU/ML. ON (B)(6) 2024, SAMPLE 3 HAD AN INITIAL INSULIN RESULT OF 17.25 UU/ML. THE SAMPLE WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS 35 UU/ML. ON (B)(6) 2024, THE SAMPLE WAS REPEATED ON THE INITIAL E602 ANALYZER AND THE RESULT WAS 35.23 UU/ML. ON (B)(6) 2024, SAMPLE 4 HAD AN INITIAL INSULIN RESULT OF 3.21 UU/ML. THE SAMPLE WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS 11.9 UU/ML. ON (B)(6) 2024, THE SAMPLE WAS REPEATED ON THE INITIAL E602 ANALYZER AND THE RESULT WAS 11.18 UU/ML. ON (B)(6) 2024, SAMPLE 5 HAD AN INITIAL INSULIN RESULT OF 6.90 UU/ML. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486535 ↗
• MalfunctionJul 8, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 29.5 IUI/ML. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 0.2 IUI/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690586 ↗
• MalfunctionApr 26, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS INSULIN RESULTS FOR 1 PATIENT ON A COBAS E 801 MODULE COMPARED TO A SIEMENS ANALYZER. ON (B)(6) 2024, A NEW SAMPLE WAS COLLECTED FROM THE SAME PATIENT AND THE INSULIN RESULT WAS 936 UUI/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 904 UUI/ML. ON (B)(6) 2024, SAMPLE WAS REPEATED ON A SIEMENS ANALYZER AND THE RESULT WAS 24.7 UUI/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197297 ↗
• MalfunctionApr 16, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLE TESTED WITH ELECSYS INSULIN ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO RIA METHOD. INITIAL RESULT: >1000 UIU/ML. ON (B)(6) 2024 THE SAMPLE WAS TESTED AT VARIOUS DILUTION FACTORS. 1:32 DILUTION RESULTED IN 50.8 UIU/ML. 1:16 DILUTION RESULTED IN 92.0 UIU/ML. 1:8 DILUTION RESULTED IN 176 UIU/ML. 1:4 DILUTION RESULTED IN 321 UIU/ML. 1:2 DILUTION RESULTED IN 616 UIU/ML. ALL THE DILUTION RESULTS WERE INTERPRETED AS SIMILAR TO THE INITIAL RESULT. THE ORIGINAL SAMPLE WAS TESTED WITH 20% PEG PRETREATMENT AND THE RESULT WAS 444 UIU/ML. THE ORIGINAL SAMPLE WAS TESTED FOR ANTI-INSULIN AB USING THE CIA METHOD AND THE RESULT WAS >175 IU/ML (REFERENCE VALUE: <20.0 IU/ML). THE ORIGINAL SAMPLE WAS THEN TESTED FOR INSULIN USING THE RIA METHOD AND THE RESULT WAS 13.09 NG/ML (REFERENCE INTERVAL: 4-16 NG/ML). THE SAMPLE WAS ALSO TESTED FOR PROINSULIN AND THE RESULT WAS 24.4. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19118301 ↗
• MalfunctionSep 26, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR 2 SAMPLES FROM 1 PATIENT TESTED FOR ELECSYS INSULIN (INSULIN) ON A COBAS E 411 IMMUNOASSAY ANALYZER. ON (B)(6) 2023 THE PATIENT HAD AN INSULIN RESULT OF 962.8 UU/ML WITH A DATA FLAG FROM THE E411 ANALYZER. THE REPEAT RESULT WAS 960.8 UU/ML WITH A DATA FLAG. ON (B)(6) 2023 A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM THE E411 ANALYZER WAS 966.0 UU/ML WITH A DATA FLAG. THIS SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE THE RESULT FROM THE MAGLUMI METHOD WAS 99.61 UU/ML AND THE RESULT FROM THE ATELLICA METHOD WAS 31.03 UU/ML

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817409 ↗
• MalfunctionMar 17, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS INSULIN ON A COBAS E 801 MODULE (SERIAL NUMBER (B)(4)). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN INSULIN VALUE OF 37.2 UU/ML AND IT REPEATED AS 19.2 UU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567198 ↗
• MalfunctionMar 14, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS INSULIN ASSAY ON A COBAS 6000 E601 MODULE, SERIAL NUMBER 26E4-17. AN INTERFERENCE IS SUSPECTED BY THE CUSTOMER. ON (B)(6) 2023, A FIRST SAMPLE FROM THE PATIENT RESULTED IN AN INSULIN VALUE OF >1000 U/L, ACCOMPANIED BY A DATA FLAG AND REPEATED ALSO WITH A VALUE OF >1000 U/L, ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2023, A SECOND SAMPLE FROM THE PATIENT RESULTED IN AN INSULIN VALUE OF >1000 U/L, ACCOMPANIED BY A DATA FLAG. THIS SAMPLE WAS REPEATED IN A DIFFERENT LABORATORY USING AN UNKNOWN METHOD, RESULTING IN AN INSULIN VALUE OF 261 MUI/ML. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541581 ↗
• MalfunctionDec 20, 2022Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS INSULIN ASSAY ON A COBAS 6000 E601 MODULE, SERIAL NUMBER (B)(4). THE RESULT DID NOT AGREE WITH THE PATIENT'S CLINICAL MANIFESTATION AND THE VALUES MEASURED USING A COMPETITOR METHOD. THE SAMPLE INITIALLY RESULTED IN AN INSULIN VALUE OF 11.31 UU/ML AND REPEATED AS 11.47 UU/ML ON A SECOND E601 MODULE. THE SAMPLE VALUES WERE REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR AND QUESTIONED. THE SAMPLE WAS THEN REPEATED USING A COMPETITOR METHOD, RESULTING IN AN INSULIN VALUE OF 300 UU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019356 ↗

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