Elecsys Tg II 08906564190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336169582), received between Jan 16, 2024 and Dec 18, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Output Problem; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TG II RESULTS FOR 1 PATIENT ON A COBAS 6000 E601 MODULE. THE CUSTOMER HAS A MEDICAL HISTORY OF TOTAL THYROIDECTOMY AND HAS HAD CONSISTENT PREVIOUS TG RESULTS OF <0.04 NG/ML SINCE 2021. ON (B)(6) 2025, THE INITIAL RESULT WAS 26.27 NG/ML. THE REPEAT RESULT WAS 27.99 NG/ML. THE PATIENT QUESTIONED THE RESULTS AND THEY WENT TO ANOTHER LABORATORY TO HAVE A NEW SAMPLE COLLECTED. THE TG RESULT FROM THE OTHER LABORATORY WAS <0.04 NG/ML. THE EXACT DATE OF TESTING WAS NOT PROVIDED. ON (B)(6) 2025, THE PATIENT HAD A NEW SAMPLE COLLECTED AND TESTED AT THE CUSTOMER SITE. AND THE TG RESULT WAS <0.04 NG/ML WITH FLAG. ON (B)(6) 2025, THE CUSTOMER REPEATED THE SAMPLE FROM (B)(6) 2025 AND THE RESULT WAS 27.76 NG/ML. THE SAMPLE FROM (B)(6) 2025 WAS ALSO REPEATED AND THE RESULT WAS <0.04 NG/ML WITH FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838443 ↗
• MalfunctionAug 26, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TG II RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: THE INITIAL RESULT FROM THE ANALYZER WAS 0.136 NG/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 0.347 NG/ML. THE DOCTOR DEEMED THE RESULT TOO HIGH FOR THE PATIENT. THE SECOND REPEAT RESULT FROM ANOTHER ROCHE ANALYZER WAS < 0.0400 NG/ML WITH A DATA FLAG. THIS RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893182 ↗
• MalfunctionSep 6, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TG II ON A COBAS E 801 MODULE. THE SAMPLE INITIALLY RESULTED IN A TG VALUE OF 1.09 NG/ML AND REPEATED AS 0.0400 NG/ML. THE SAMPLE WAS REPEATED FOUR TIMES ON (B)(6) 2024, RESULTING IN TG VALUES OF 0.0447 NG/ML, 0.509 NG/ML, 0.493 NG/ML, AND 0.499 NG/ML. THE SAMPLE WAS REPEATED THREE TIMES ON (B)(6) 2024, EACH TIME RESULTING IN TG VALUES OF 0.0400 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158790 ↗
• MalfunctionJan 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Insufficient Device Problem Information; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Insufficient Device Problem Information

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TG II ON A COBAS E 801 MODULE. THE RESULTS DID NOT COMPARE TO COMPETITOR TEST RESULTS. THE SAMPLE RESULTED IN A TG VALUE OF 96.2 NG/ML (REFERENCE RANGE = 3.5 - 7.7 NG/ML) WHEN TESTED ON THE E801 ANALYZER WITH REAGENT LOT NUMBER 702150. THE SAMPLE WAS REPEATED ON THE E801 ANALYZER USING REAGENT LOT NUMBER 730633, RESULTING IN A TG VALUE OF 98.2 NG/ML. THE PLASMA TUBE OF THE SAME SAMPLE WAS REPEATED ON THE E801 ANALYZER USING REAGENT LOT NUMBER 730633, RESULTING IN A TG VALUE OF 91.1 NG/ML. THE SAMPLE WAS REPEATED USING TWO DIFFERENT COMPETITOR METHODS. WITH THE FIRST METHOD, THE TG RESULT WAS < 0.14 NG/ML. WITH THE SECOND METHOD, THE TG RESULT WAS 0.13 NG/ML. BOTH COMPETITOR VALUES ARE WITHIN THEIR RESPECTIVE NORMAL REFERENCE RANGES. THE CUSTOMER DEEMED THE COMPETITOR'S RESULTS TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516838 ↗