Elecsys T3 09007733190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613336171653), received between Mar 28, 2023 and Jan 26, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T3 RESULTS FOR 2 PATIENT SAMPLES TESTED ON COBAS E 801 ANALYTICAL UNITS. 2. PATIENT AGE RANGE: 4-66 YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 2-MALE. 5. PATIENT RACE BREAKDOWN: 1-ASKU, 1-ASIAN. 6. PATIENT ETHNICITY BREAKDOWN: 1-ASKU, 1-NON-HISPANIC/LATINO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183968 ↗
• MalfunctionJul 24, 2025High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT TESTED WITH ELECSYS T3 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 22587467 ↗
• MalfunctionApr 29, 2025Incorrect Measurement; Chemical Problem; Incorrect Measurement; Chemical Problem

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T3 RESULTS FOR APPROXIMATELY 60 SAMPLES 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 21925105 ↗
• 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 T3. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T4 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 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 21306968 ↗
• MalfunctionJan 29, 2025Low Test Results; Low Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T3 RESULTS FOR 1 PATIENT ON A COBAS 8000 CORE 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 21266820 ↗
• MalfunctionDec 20, 2023High Test Results; Chemical Problem; High Test Results; Chemical Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T3, ELECSYS T4 ASSAY, AND ELECSYS TSH ASSAY RESULTS FOR 6 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO TREE COMPETITOR ANALYZERS. THIS MEDWATCH WILL COVER T3. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T4 RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE UNITS OF MEASUREMENT FOR THE TSH RESULTS AND FOR THE COMPETITOR ANALYZER RESULTS WERE NOT PROVIDED. THE REFERENCE RANGES FOR ALL ASSAYS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365973 ↗
• MalfunctionDec 15, 2023False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T3, ELECSYS T4 ASSAY, ELECSYS FT3 III, ELECSYS FT4 III ASSAY, ELECSYS ANTI-TPO, AND ELECSYS ANTI-TG RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE COMPARED TO AN ABBOTT ANALYZER. THIS MEDWATCH WILL COVER T3. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T4 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TPO RESULTS, AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TG RESULTS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335905 ↗
• MalfunctionNov 29, 2023Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS T3 AND ELECSYS T4 ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER STATES THAT THE T3 AND T4 VALUES WERE ABNORMALLY ELEVATED, BUT TSH WAS NORMAL. THE RESULTS WERE NOT IN LINE WITH THE PATIENT'S CLINICAL MANIFESTATIONS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE T3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE T4 ASSAY. REFER TO THE ATTACHMENT FOR THE PATIENT'S RESULTS. THE T3 AND T4 VALUES FROM THE (B)(6) 2023 SAMPLE ARE QUESTIONED. THE SAMPLE WAS REPEATED AFTER THE PATIENT SAMPLE WAS TREATED WITH THE STREPTAVIDIN-COATED MICROPARTICLE PORTION OF THE T3 AND T4 REAGENTS. FOR THIS TREATMENT, THE SAMPLE AND MICROPARTICLE PORTION OF THE REAGENTS WERE INCUBATED AT 37 DEGREES CELCIUS FOR 30 MINUTES, THE SUPERNATANT WAS THEN CENTRIFUGED AND TESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18232764 ↗
• MalfunctionMay 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER T3. 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 FT4 RESULTS, AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULTS AS THEY DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE ANALYZER SERIAL NUMBER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955691 ↗
• MalfunctionMar 28, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS T3 AND ELECSYS T4 ASSAY RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS E 801 MODULE WITH UNKNOWN SERIAL NUMBER. THE REPORTER STATED THAT THE RESULTS THEY OBTAINED FROM THE MODULE WERE SIGNIFICANTLY HIGHER THAN THOSE FROM AN ABBOTT SYSTEM. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH IS FOR THE T3 ASSAY. PLEASE REFER TO MEDWATCH WITH PATIENT IDENTIFIER: (B)(6) FOR THE T4 ASSAY. PLEASE REFER TO THE ATTACHMENT IN THE MEDWATCH FOR THE TABLE CONTAINING THE QUESTIONABLE RESULTS. THE REPORTER STATED THAT THE RESULTS FROM EACH METHOD WERE NOT PRESENTING THE SAME CLINICAL INTERPRETATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16631539 ↗