Elecsys Troponin T Gen 5Recalls & reported problems across all models

We found 2 models of Elecsys Troponin T Gen 5 by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between Nov 2, 2022 and Sep 24, 2026 — classified as 87 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (63 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 Troponin T Gen 5 problems

Elecsys Troponin T Gen 5 models

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

• Elecsys Troponin T Gen 5 08469890160

  IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  58 reports
• Elecsys Troponin T Gen 5 08469865160

  IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  29 reports

Recent Elecsys Troponin T Gen 5 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882043 ↗
• MalfunctionSep 23, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872993 ↗
• MalfunctionSep 23, 2026High Test Results

  We received an allegation about discrepant results for 1 patient sample tested with Elecsys Troponin T Gen 5 assay on a cobas e 801 analytical unit.The initial result was 309 ng/L.Since the patient did not have any cardiac symptoms, the physician questioned the initial result and requested a repeat of the sample.The sample was repeated on the same e 801, and the 1st Repeat result was <6 ng/L (accompanied by a data flag). This result was not reported outside the laboratory.The sample was then retested on a different instrument, and the 2nd Repeat result was <6 ng/L (accompanied by a data flag).The repeat results were deemed to be correct.The 2nd Repeat result was reported outside the laboratory.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865755 ↗
• MalfunctionApr 17, 2026High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE ANALYZER WAS 23.9 NG/L. THE REPEAT RESULT FROM THE ANALYZER WAS 11.7 NG/L. THE REPEAT RESULT FROM ANOTHER COBAS ANALYZER WAS 11.4 NG/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S FIRST RESULT OF 12.5 NG/L, PROMPTING THE RERUN. THE PATIENT'S THIRD RESULT AFTER TWO HOURS WAS 12.0 NG/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910472 ↗
• MalfunctionApr 17, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULTS FOR 4 PATIENT SAMPLES ON TWO COBAS E 801 ANALYTICAL UNITS. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLES AS THE INITIAL RESULTS DID NOT MATCH THE PATIENTS' CLINICAL HISTORY. ON (B)(6) 2026, SAMPLE 1 HAD AN INITIAL RESULT OF 52 NG/L ON ANALYZER (B)(6). THE REPEAT RESULT WAS 31 NG/L. ON (B)(6) 2026, SAMPLE 2 HAD AN INITIAL RESULT OF 19.2 NG/L ON ANALYZER (B)(6) THE REPEAT RESULT WAS 8.99 NG/L. THE SAMPLE WAS ALSO REPEATED TWICE ON ANALYZER (B)(6) AND THE RESULTS WERE 6.67 NG/L AND <6.0 NG/L. ON (B(6) 2026, SAMPLE 3 HAD AN INITIAL RESULT OF 18.6 NG/L ON ANALYZER (B)(6) THE REPEAT RESULT FROM ANALYZER (B)(6) WAS 11.4 NG/L. ON (B)(6) 2026, SAMPLE 4 HAD AN INITIAL RESULT OF 12.4 NG/L ON ANALYZER (B)(6) THE REPEAT RESULT WAS 6.12 NG/L. THE SAMPLE WAS REPEATED ON ANALYZER (B)(6) AND THE RESULT WAS <6.0 NG/L. THE SAMPLE WAS ALSO REPEATED ON ANALYZER (B)(6) AND THE RESULT WAS <6.0 NG/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910467 ↗
• MalfunctionApr 3, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULTS FOR 3 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 34 NG/L, AND THE REPEATED RESULT WAS 10 NG/L. PATIENT 2: THE INITIAL RESULT WAS 16 NG/L, AND THE REPEATED RESULT WAS 6 NG/L. PATIENT 3: THE INITIAL RESULT WAS 12 NG/L, AND THE REPEATED RESULT WAS 6 NG/L. THE SAMPLES WERE REPEATED BECAUSE THE DOCTOR QUESTIONED THE RESULTS. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778607 ↗
• MalfunctionMar 30, 2026Low Test Results; Output Problem; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS TROPONIN T GEN 5 STAT ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM). SAMPLE 1: INITIAL RESULT: 9.7 NG/L. REPEAT RESULT: 18.4 NG/L. SAMPLE 2: INITIAL RESULT: 15.8 NG/L. REPEAT RESULTS: 65.1 NG/L AND 64.7 NG/L. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730967 ↗
• MalfunctionMar 30, 2026High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TROPONIN T GEN 5 ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 78.5 NG/L. THE INITIAL RESULT WAS QUESTIONED, PROMPTING THE REPEAT OF THE SAMPLE ON THE SAME ANALYTICAL UNIT AND ON A DIFFERENT COBAS E 801 ANALYTICAL UNIT. THE REPEAT RESULTS WERE BOTH <6 NG/L AND DEEMED TO BE CORRECT. AN AMENDED REPORT WITH THE CORRECT RESULT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714796 ↗
• MalfunctionMar 26, 2026High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS TROPONIN T GEN5 ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: 215 NG/L (TESTED ON MEASURING CELL 1). THE INITIAL RESULT WAS HIGH, PROMPTING THE REPEAT OF THE SAMPLE PER THE CUSTOMER'S STANDARD OPERATING PROCEDURE FOR CRITICALLY HIGH TROPONIN VALUES. REPEAT RESULT: 25.9 NG/L (TESTED ON MEASURING CELL 2). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701981 ↗
• MalfunctionMar 26, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 STAT RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 306 NG/L. THE CUSTOMER QUESTIONED THE HIGH RESULT WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER E601 ANALYZER AND THE RESULT WAS 12.85 NG/L. THE REPEAT RESULT WAS DEEMED CORRECT. THE PATIENT HAD A NEW SAMPLE COLLECTED AND TESTED ON BOTH E601 ANALYZERS AND THE RESULTS WERE BOTH WITHIN NORMAL RANGE. THE EXACT RESULTS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701960 ↗
• MalfunctionMar 17, 2026Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TROPONIN T GEN 5 ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF 2181 NG/L. THE SAMPLE WAS REPEATED THREE ADDITIONAL TIMES, RESULTING IN VALUES OF 1804 NG/L, 1770 NG/L, AND 1770 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616179 ↗
• MalfunctionMar 16, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HIGH ELECSYS TROPONIN T GEN 5 RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THERE WERE THREE SAMPLES COLLECTED. THE FIRST SAMPLE RESULT WAS 8 NG/L. THE QUESTIONABLE RESULTS WERE ON THE SECOND SAMPLE: THE INITIAL RESULT FOR THE SECOND SAMPLE WAS 18 NG/L, AND THE REPEAT RESULT WAS 9 NG/L. THE SAMPLE WAS REPEATED AFTER THE DOCTOR QUESTIONED THE INITIAL RESULTS. THE THIRD SAMPLE RESULT WAS 8 NG/L. THE LOWER RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608105 ↗
• MalfunctionFeb 25, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 208 NG/L, AND THE REPEAT RESULT WAS 26 NG/L. THE REPEAT RESULT ON ANOTHER E 801 WAS 18 NG/L. THE RESULT OF 18 NG/L WAS DEEMED TO BE CORRECT. THE PHYSICIAN REQUESTED THAT THE SAMPLE BE REPEATED AFTER SAMPLES FROM A 2-HOUR CHECK HAD LOWER RESULTS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442098 ↗
• MalfunctionFeb 18, 2026High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE RESULT FROM SAMPLE 1 (ZERO-HOUR) WAS 86.1 NG/L. THIS SAMPLE WAS NOT REPEATED. ANOTHER SAMPLE WAS OBTAINED 1 HOUR LATER (SAMPLE 2), AND THE RESULT WAS 7.63 NG/L. BASED ON THE RESULT DISCREPANCY BETWEEN THE FIRST SAMPLE AND THE SECOND SAMPLE, THE SECOND SAMPLE WAS REPEATED, AND THE RESULT WAS 85.3 NG/L. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379927 ↗
• MalfunctionFeb 11, 2026Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS <6 NG/L WITH A DATA FLAG. THE REPEAT RESULT WAS 186 NG/L. THE REPORTER QUESTIONED THE DISCREPANT RESULTS, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315845 ↗

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