Elecsys Troponin T Gen 5 08469890160Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 07613336158982), received between Nov 2, 2022 and Sep 24, 2026 — classified as 58 malfunctions.

The most frequently reported specific device problem is “High Test Results” (45 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, 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 25 most recent of 58 reports, 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, 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 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 ↗
• MalfunctionJan 22, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 25 NG/L, AND THE REPEATED RESULT WAS 9.91 NG/L. PATIENT 2: THE INITIAL RESULT WAS 13 NG/L, AND THE REPEATED RESULT WAS 31 NG/L. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE AND WERE BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED DUE TO "ABNORMALLY HIGH" RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151792 ↗
• MalfunctionJan 8, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 555 NG/L. THE CUSTOMER REPEATED THE SAMPLE AS THEY HAVE AN INTERNAL POLICY TO REPEAT ALL SAMPLES THAT GIVE CRITICAL VALUES. THE REPEAT RESULT WAS 8 NG/L. THE SAMPLE WAS REPEATED AGAIN ON ANOTHER ANALYZER AND THE RESULT WAS 8 NG/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001603 ↗
• MalfunctionDec 17, 2025High Test Results; Output Problem; Non Reproducible Results; High Test Results; Output Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 39.09 PG/ML. A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 10.34 PG/ML. THE ORIGINAL AND THE NEW SAMPLES WERE REPEATED AND THE RESULTS WERE 10.86 PG/ML AND 10.75 PG/ML, RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829591 ↗
• MalfunctionDec 11, 2025Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 127 NG/L. THE HIGH RESULT WAS QUESTIONED BY THE TECHNICIAN, AND THE SAMPLE WAS REPEATED. THE REPEATED RESULTS WERE 9 NG/L AND 11 NG/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS <7 NG/L. THE RESULT OF 9 NG/L WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778450 ↗
• MalfunctionDec 10, 2025Low Test Results; Non Reproducible Results; Low 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 174 NG/L. THE SAMPLE WAS REPEATED MULTIPLE TIMES. SOME RESULTS ARE FROM A DIFFERENT ANALYZER, BUT IT IS NOT SPECIFIED WHICH RESULTS. THE FIRST REPEAT RESULT WAS 209 NG/L. THE SECOND REPEAT RESULT WAS 210 NG/L. THE THIRD REPEAT RESULT WAS 205 NG/L. THE REPEAT RESULT OF 205 NG/L WAS DEEMED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE CUSTOMER HAS A RULE TO REPEAT THE SAMPLE IF THE RESULT IS GREATER THAN 100 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769581 ↗
• MalfunctionDec 5, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. SAMPLE 1 INITIAL RESULT WAS 25.9 NG/L, AND THE REPEAT RESULT WAS 14.7 NG/L. WHEN REPEATED ON ANOTHER ANALYZER, THE RESULT WAS 16.3 NG/L. ON (B)(6) 2025, SAMPLE 2 INITIAL RESULT WAS 19 NG/L, AND THE REPEAT RESULT WAS <6 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728708 ↗
• MalfunctionNov 21, 2025High Test Results; Non Reproducible Results; High 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 602 MODULE. THE INITIAL RESULT WAS 44 NG/L. THE FIRST REPEAT RESULT WAS 56 NG/L. THE SECOND REPEAT RESULT WAS 44 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618018 ↗
• MalfunctionNov 17, 2025Incorrect Measurement; High Test Results; Low Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Low 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. INITIAL RESULT: 4936 NG/L. THE CUSTOMER REPEATED THE SAMPLE, AS THERE IS A PROTOCOL TO REPEAT ALL SAMPLES WITH TROPONIN T RESULTS >100 NG/L. REPEAT RESULT: 6125 NG/L (TESTED A DIFFERENT E 801 ANALYTICAL UNIT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567903 ↗
• MalfunctionNov 11, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Output Problem; Non Reproducible Results; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Output Problem; 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. INITIAL RESULT: 843 NG/L. THE INITIAL RESULT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT OF 20.88 NG/L, PROMPTING THE REPEAT OF THE SAMPLE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. REPEAT RESULT: 23.68 NG/L. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525126 ↗
• MalfunctionNov 10, 2025High Test Results; Non Reproducible Results; High 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 INITIAL RESULT WAS 758 NG/L. THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED THAT THE SAMPLE BE REPEATED. THE INITIAL RESULT WAS QUESTIONED AS IT DID NOT FIT THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 8 NG/L. THIS RESULT WAS BELIEVED TO BE CORRECT. TWO NEW SAMPLES WERE OBTAINED FROM THE PATIENT. ONE OF THE SAMPLES PRODUCED A RESULT OF 9 NG/L, AND THE OTHER SAMPLE PRODUCED A RESULT OF 8 NG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512844 ↗
• MalfunctionOct 27, 2025High 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 TROPONIN T GEN 5 (TROPONIN T) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.00 NG/L WITH A DATA FLAG. THE NURSE QUESTIONED THIS RESULT AS IT WAS DIFFERENT THAN THE PREVIOUS RESULT OF 1221 NG/L. THE SAMPLE WAS REPEATED WITH A RESULT OF 1213 NG/L. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389452 ↗
• MalfunctionJun 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; 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 INITIAL RESULT WAS 15 NG/L THE RESULT AT THE 1-HOUR MARK WAS 52.2 NG/L. THE DOCTOR QUESTIONED THE RESULT AND REQUESTED THAT THE SAMPLE BE REPEATED. THE REPEATED RESULT WAS 15 NG/L. THE RESULT AT THE 3-HOUR MARK WAS 15 NG/L. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22229254 ↗