Elecsys T4 09007784190Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613336171677), received between Aug 15, 2022 and Jun 5, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “High Test Results” (14 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 18 most recent of 18 reports, 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 ↗
• 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, 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, 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 ↗
• MalfunctionFeb 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 ASSAY RESULTS FOR 3 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER QUESTIONED THE HIGH INITIAL RESULTS WHICH PROMPTED THEM TO REPEAT THE SAMPLES. FOR SAMPLE 1, THE INITIAL T4 RESULT WAS 24.9 UG/DL WITH FLAG. THE SAMPLE WAS REPEATED AND THE REPEAT RESULT WAS 13.9 UG/DL. THE SAMPLE WAS REPEATED A THIRD TIME THE NEXT DAY AND THE RESULT WAS 8.56 UG/DL. FOR SAMPLE 2, THE INITIAL T4 RESULT WAS 24.9 UG/DL WITH FLAG. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE REPEAT RESULT WAS 8.47 UG/DL. FOR SAMPLE 3, THE INITIAL T4 RESULT WAS 24.9 UG/DL WITH FLAG. THE SAMPLE WAS REPEATED AND THE REPEAT RESULT WAS 8.60 UG/DL. THE SAMPLE WAS REPEATED A THIRD TIME THE NEXT DAY AND THE RESULT WAS 8.63 UG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18801756 ↗
• MalfunctionDec 6, 2023Incorrect Measurement; Manufacturing, Packaging or Shipping Problem; Incorrect Measurement; Manufacturing, Packaging or Shipping Problem

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 7 PATIENT SAMPLES TESTED FOR ELECSYS T4 (T4) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FOR ALL 7 PATIENT SAMPLES WAS >24.9 UG/DL WITH A DATA FLAG. PATIENT 1 REPEAT RESULT WAS 5.97 UG/DL. PATIENT 2 REPEAT RESULT WAS 5.55 UG/DL. PATIENT 3 REPEAT RESULT WAS 3.91 UG/DL. PATIENT 4 REPEAT RESULT WAS 4.16 UG/DL. PATIENT 5 REPEAT RESULT WAS 8.74 UG/DL. PATIENT 6 REPEAT RESULT WAS 5.65 UG/DL. PATIENT 7 REPEAT RESULT WAS 5.10 UG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277792 ↗
• MalfunctionSep 13, 2023High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESYULTS FOR 1 PATIENT'S SERUM SAMPLE TESTED WITH ELECSYS THYROXINE (T4) ON A COBAS E801 IMMUNOASSAY ANALYZER. INITIAL RESULT: 18 G/DL. THIS RESULT WAS CONSIDERED HIGH AND IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. REPEAT RESULT: 7.66 G/DL. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY BUT THE CUSTOMER NOTICED AND DELETED IT FROM THE PATIENT'S RECORD BEFORE THE PHYSICIAN ACCESSED THE RESULT. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17735352 ↗
• MalfunctionJun 15, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A BECKMAN ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. CLARIFICATION ON IF THE RESULTS FROM (B)(6) 2023 WERE FROM A NEW SAMPLE WAS REQUESTED BUT NOT PROVIDED. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136179 ↗
• 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 T4 ASSAY. PLEASE REFER TO MEDWATCH WITH PATIENT IDENTIFIER: (B)(6) FOR THE T3 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 16631540 ↗
• MalfunctionAug 15, 2022High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS T3 (T3), ELECSYS FT3 III (FT3 III) AND ELECSYS T4 (T4) ON A COBAS 8000 CORE UNIT COMPARED TO THE SIEMENS METHOD. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS. THE T3 RESULT FROM THE ROCHE METHOD WAS 3.56 NG/ML. THE RESULT FROM THE SIEMENS METHOD WAS 1.13 NG/ML. THE FT3 III RESULT FROM THE ROCHE METHOD WAS 7.26 PG/ML. THE RESULT FROM THE SIEMENS METHOD WAS 3.22 PG/ML. THE T4 RESULT FROM THE ROCHE METHOD WAS 24.9 UG/DL. THE RESULT FROM THE SIEMENS METHOD WAS 7.78 UG/DL. THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL CONDITION. THE SIEMENS RESULTS WERE BELIEVED TO BE "NORMAL." THE COBAS 8000 CORE UNIT SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224980 ↗