Elecsys Troponin T 4491815190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630920938), received between Feb 10, 2023 and Mar 31, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 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 THE ELECSYS TROPONIN T ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF 18 NG/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. A DOCTOR QUESTIONED THE RESULT, SO THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 5 NG/L. THE REPEAT VALUE WAS DEEMED CORRECT. THE TROPONIN T REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657503 ↗
• MalfunctionFeb 10, 2023High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT RESULT FOR 1 PATIENT TESTED FOR TROPONIN T (TNT) ON A COBAS E801 ANALYZER. THE INITIAL TNT RESULT WAS 0.0364 NG/ML. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AS WELL AS ANOTHER ANALYZER, RESULTING AS 0.003 NG/ML WITH A DATA FLAG BOTH TIMES. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. TWO MORE SAMPLES FROM THE PATIENT RESULTED IN TNT VALUES OF 0.003 NG/ML WITH A DATA FLAG. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16357761 ↗