Elecsys T4Recalls & reported problems across all models

We found 3 models of Elecsys T4 by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2018 and Jun 5, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “High Test Results” (23 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 T4 problems

Elecsys T4 models

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

• Elecsys T4 09007784190

  Radioimmunoassay, total thyroxine
  18 reports
• Elecsys T4 07027885190

  Radioimmunoassay, total thyroxine
  11 reports
• Elecsys T4 09007741190

  Radioimmunoassay, total thyroxine
  5 reports

Recent Elecsys T4 adverse event reports

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

• MalfunctionJun 5, 2026High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE THYROID ASSAY RESULTS FOR ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS T4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) FOR THE ELECSYS FT4 IV ASSAY. (B)(6) FOR THE ELECSYS T3 ASSAY. (B)(6) FOR THE ELECSYS FT3 III ASSAY. AN INTERFERENT IS SUSPECTED FOR THESE ASSAYS. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) - FOR THE QUESTIONABLE ELECSYS ANTI-TPO ASSAY RESULTS. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE TABLE CONTAINING THE QUESTIONABLE RESULTS FROM THE ANALYZER COMPARED WITH THE ASSAY RESULTS FROM A BECKMANN ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410985 ↗
• MalfunctionJan 26, 2026Non Reproducible Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 RESULTS FOR ONE PATIENT FROM THE COBAS E411 RACK ANALYZER. 2. PATIENT AGE RANGE: ASKU, 3. PATIENT WEIGHT RANGE: ASKU, 4. PATIENT SEX BREAKDOWN: ASKU, 5. PATIENT RACE BREAKDOWN: ASKU, 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183967 ↗
• MalfunctionOct 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 RESULTS FOR ONE PATIENT FROM THE COBAS 6000 E601 MODULE. 2. PATIENT AGE RANGE: 53 YEAR. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: MALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369188 ↗
• MalfunctionJul 24, 2025High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT TESTED WITH ELECSYS T4 ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587464 ↗
• MalfunctionJul 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Low Readings

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS T4 ON A COBAS 6000 E601 MODULE. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587462 ↗
• MalfunctionJul 24, 2025False Positive Result; False Positive Result

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: ASKU, 3. PATIENT WEIGHT RANGE: ASKU, 4. PATIENT SEX BREAKDOWN: ASKU, 5. PATIENT RACE BREAKDOWN: ASKU, 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587461 ↗
• MalfunctionFeb 4, 2025High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. OF THE DATA PROVIDED, THE RESULTS FOR FT3, T4, T3, ANTI-TG AND ANTI-TPO WERE DISCREPANT. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TG RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TPO RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306967 ↗
• MalfunctionJan 30, 2025Low Test Results; Chemical Problem; Low Test Results; Chemical Problem

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 RESULTS FOR 1 PATIENT FROM THE COBAS E411 DISK ANALYZER. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275399 ↗
• MalfunctionJan 30, 2025High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS T4 ON A COBAS E801 ANALYTICAL UNIT AND FOR 1 PATIENT TESTED FOR ELECSYS T4 ON A COBAS 8000 E 602 MODULE. 2. PATIENT AGE RANGE: ASKU, 3. PATIENT WEIGHT RANGE: ASKU, 4. PATIENT SEX BREAKDOWN: ASKU, 5. PATIENT RACE BREAKDOWN: ASKU, 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273320 ↗
• MalfunctionJan 29, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR ELECSYS T4 ON A COBAS 8000 E 801 MODULE COMPARED TO AN UNSPECIFIED CHEMILUMINESCENCE METHOD. 2. PATIENT AGE RANGE: (B)(6). 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: FEMALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266846 ↗
• MalfunctionNov 4, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS T4 (T4), ELECSYS FT3 III VER.2, AND ELECSYS T3 (T3) ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS T4 (T4) ASSAY. PLEASE REFER TO THE MEDWATCH WITH: A1. PATIENT IDENTIFIER: (B)(6) FOR THE ELECSYS FT3 III VER.2 ASSAY. A1. PATIENT IDENTIFIER: (B)(6) FOR THE ELECSYS T3 (T3) ASSAY. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20601092 ↗
• MalfunctionOct 25, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS T4 (T4) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 16.9 MG/DL. THIS RESULT WAS DEEMED TOO HIGH FOR THE "PATIENT'S CLINIC". THE FIRST REPEAT RESULT WAS 5.78 MG/DL. THE SECOND REPEAT RESULT WAS 5.46 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533698 ↗
• MalfunctionOct 23, 2024High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR 22 PATIENTS FOR ELECSYS T4 FROM THREE COBAS E 801 MODULE ANALYZERS. 2. PATIENT AGE RANGE: 3 ARE 3 - 72 YEARS, 19 ARE ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 1 FEMALE, 1 MALE, 20 ASKU. 5. PATIENT RACE BREAKDOWN: 2 ASIAN, 20 ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516091 ↗
• MalfunctionOct 2, 2024High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 RESULTS FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 17.9 G/DL AND THE REPEAT RESULT WAS 7.87 G/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353244 ↗
• MalfunctionMar 4, 2024Mechanical Problem; Non Reproducible Results; Mechanical Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE T4 RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. AFTER A FAILED CALIBRATION, THE CUSTOMER REPEATED THREE PATIENT SAMPLES FOR A PATIENT CORRELATION. SAMPLE 1 INITIAL RESULT WAS 9.29 UG/DL AND THE REPEAT RESULT WAS 13.2 UG/DL. SAMPLE 2 INITIAL RESULT WAS 5.86 UG/DL AND THE REPEAT RESULT WAS 10.9 UG/DL. SAMPLE 3 INITIAL RESULT WAS 7.3 UG/DL AND THE REPEAT RESULT WAS 11.6 UG/DL. THE INITIAL RESULTS WERE BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825458 ↗

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