Elecsys FT3 III 09005811190Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 07613336171578), received between Nov 22, 2021 and Sep 28, 2026 — classified as 134 malfunctions.

The most frequently reported specific device problem is “High Test Results” (114 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 25 most recent of 134 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917884 ↗
• MalfunctionApr 27, 2026Low Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT3 III ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE MINDRAY METHOD. 2. PATIENT AGE RANGE: 11 YEARS 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 25002377 ↗
• MalfunctionDec 22, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT4 IV ASSAY, ELECSYS FT3 III ASSAY, ELECSYS VITAMIN D TOTAL III ASSAY, ELECSYS SHBG ASSAY, ELECSYS TESTOSTERONE II ASSAY, ELECSYS CORTISOL II ASSAY, ELECSYS PROLACTIN II ASSAY, ELECSYS FSH ASSAY, AND ELECSYS ANTI-TG ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE VITAMIN D TOTAL III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE SHBG ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TESTOSTERONE II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CORTISOL II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE PROLACTIN II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FSH ASSAY, AND TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866276 ↗
• MalfunctionOct 23, 2025Non Reproducible Results; Non Reproducible Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III 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 23369488 ↗
• MalfunctionJul 24, 2025High Test Results; High Test Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 3 PATIENTS FROM COBAS E 801 ANALYTICAL UNITS AND 2 PATIENTS FROM COBAS 8000 CORE UNITS. 2. PATIENT AGE RANGE: ASKU, 19-69. YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 2-FEMALE, 1-MALE, 2-ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586746 ↗
• MalfunctionMay 27, 2025High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III, ELECSYS FT4 IV, AND ELECSYS ANTI-TSHR ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE RESULTS MEASURED ON THE E 801 ANALYZER DID NOT COMPARE TO RESULTS MEASURED USING THE ABBOTT METHODS. THIS MEDWATCH WILL APPLY TO THE FT3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY AND REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TSHR ASSAY. THE RESULTS MEASURED ON THE E 801 ANALYZER ARE AS FOLLOWS: FT3 = 12.2 PMOL/L (REFERENCE RANGE = 3.1 - 6.8 PMOL/L), FT4 = 59.9 PMOL/L (REFERENCE RANGE = 12 - 22 PMOL/L), ANTI-TSHR TESTED ON (B)(6) 2025 = 14.00 IU/L (POSITIVE). THE RESULTS MEASURED USING THE ABBOTT METHOD ARE AS FOLLOWS: FT3 = 4.08 PMOL/L (REFERENCE RANGE = 3.45 - 5.5 PMOL/L), FT4 = 14.08 PMOL/L (REFERENCE RANGE = 11.0 - 17.7 PMOL/L), ANTI-TSHR TESTED ON (B)(6) 2025 = <0.7 IU/L (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088283 ↗
• MalfunctionApr 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 FT3 III 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 21925117 ↗
• MalfunctionApr 29, 2025High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THERE WERE ALLEGATIONS OF DISCREPANT HIGH RESULTS FOR 6 PATIENTS TESTED FOR ELECSYS FT3 III. THE EVENTS INVOLVED 2 COBAS 8000 E 801 MODULES, 2 COBAS 8000 CORE UNITS, A COBAS 6000 E601 MODULE, AND A COBAS E 602 MODULE. 2. PATIENT AGE RANGE: 1 ASKU, 40 - 79 YEARS. 3. PATIENT WEIGHT RANGE: 6 ASKU. 4. PATIENT SEX BREAKDOWN: 2 ASKU, 4 FEMALES. 5. PATIENT RACE BREAKDOWN: 6 ASKU. 6. PATIENT ETHNICITY BREAKDOWN: 6 ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925101 ↗
• 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 FT3. 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 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 21306974 ↗
• MalfunctionJan 30, 2025Low Test Results; Low Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III 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 21273003 ↗
• 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 FT3 III VER.2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH: A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS T4 (T4) 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. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20602073 ↗
• MalfunctionApr 29, 2024High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH ELECSYS FT3 III RESULTS FOR 2 PATIENT SAMPLES. 2. PATIENT AGE RANGE: 1 PATIENT: 86 YEARS, OTHER: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 1 F, 1 ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203011 ↗
• MalfunctionApr 22, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III AND ELECSYS FT4 IV ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(4). FOR INFORMATION ON THE FT4 IV RESULTS. THE DOCTOR QUESTIONED THE ROCHE RESULTS WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE ON A COMPETITOR ANALYZER. THE SAMPLE HAD A ROCHE FT3 RESULT OF 8.20 PMOL/L AND A ROCHE FT4 RESULT OF 1.98 NG/DL. THE ROCHE FT3 REFERENCE RANGE IS 3.1 - 6.8 PMOL/L. THE ROCHE FT4 REFERENCE RANGE IS 0.92 - 1.68 NG/DL. THE SAMPLE HAD AN ABBOTT FT3 RESULT OF 4.58 PMOL/L AND AN ABBOTT FT4 RESULT OF 11.2 PMOL/L. THE ABBOTT FT3 REFERENCE RANGE IS 2.43 - 6.00 PMOL/L. THE ABBOTT FT4 REFERENCE RANGE IS 9.01 - 19.05 PMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153798 ↗
• MalfunctionApr 22, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON TWO COBAS E 801 MODULE COMPARED TO AN ABBOTT ARCHITECT ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153552 ↗
• MalfunctionApr 17, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY ON A COBAS 8000 E801 MODULE COMPARED TO A NON-ROCHE ANALYZER (SN (B)(6). REFER TO THE ATTACHMENT FOR THE PATIENT¿S DATA. ON (B)(6) 2024 THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER. THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL SYMPTOMS AND, THEREFORE, THE SAMPLE WAS THEN REPEATED ON A NON-ROCHE ANALYZER (SN (B)(6). THE SAMPLE WAS ALSO REPEATED ON A ROCHE ANALYZER AND THE REPEAT RESULTS WERE THE SAME AS THE INITIAL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125670 ↗
• MalfunctionApr 16, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III (FT3 III) AND ELECSYS FT3 III VER. 2 (FT3 III V 2) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 E 801 MSB/MSBL. THE REPORTER SUSPECTS THE INITIAL RESULT WAS A FALSE POSITIVE CAUSED BY AN INTERFERENCE IN THE PATIENT SAMPLE. THIS MDR IS FOR THE FT3 III V 2 ASSAY. PLEASE REFER TO MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR THE FT3 III ASSAY PLEASE REFER TO THE ATTACHMENT PT (B)(6) FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19118967 ↗
• MalfunctionMar 27, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III ON TWO COBAS E 801 MODULE ANALYZERS AND A COBAS E 411 ANALYZER. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER ON (B)(6)2024. THE SAMPLE WAS REPEATED USING THE WAKO ACCURASEED AND ABBOTT ALINITY METHODS. THE SAMPLE WAS ALSO TREATED WITH A 25% POLYETHYLENE GLYCOL (PEG) SOLUTION AND REPEATED ON THE E801 ANALYZER. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E801 ANALYZER AND AN E411 ANALYZER ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985248 ↗
• MalfunctionMar 22, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY AND FT4 G4 (FT4 IV) ASSAY ON A COBAS 8000 E801 MODULE. THE SAMPLE ALSO HAD DISCREPANT RESULTS WHEN TESTED ON ANOTHER COBAS 8000 E801 MODULE AND ON A COBAS E411 IMMUNOASSAY ANALYZER. THIS MEDWATCH WILL APPLY TO THE FT3 III V2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS INITIALLY TESTED AND REPEATED ON THE CUSTOMER'S E801 ANALYZER ON (B)(6) 2024. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A 2ND E801 ANALYZER AND E411 ANALYZER ON (B)(6)2024. THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959117 ↗
• MalfunctionMar 22, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY AND FT4 G4 (FT4 IV) ASSAY ON A COBAS 8000 E801 MODULE. THE SAMPLES ALSO HAD DISCREPANT RESULTS WHEN TESTED ON ANOTHER COBAS 8000 E801 MODULE AND ON A COBAS E411 IMMUNOASSAY ANALYZER. THIS MEDWATCH WILL APPLY TO THE FT4 IV ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE FT3 III V2 ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS INITIALLY TESTED AND REPEATED ON THE CUSTOMER'S E801 ANALYZER ON (B)(6) 2024. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A 2ND E801 ANALYZER AND E411 ANALYZER ON (B)(6) 2024. THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959097 ↗
• MalfunctionMar 18, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III ON TWO COBAS E 801 MODULE ANALYZERS AND A COBAS E 411 ANALYZER. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER ON 02-FEB-2024. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E801 ANALYZER AND AN E411 ANALYZER ON (B)(6) 2024. THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924525 ↗
• MalfunctionMar 12, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III ON TWO COBAS E 801 MODULE ANALYZERS AND A COBAS E 411 ANALYZER. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER ON (B)(6) 2024. THE SAMPLE WAS REPEATED USING THE WAKO ACCURASEED AND ABBOTT ALINITY METHODS. THE SAMPLE WAS ALSO TREATED WITH A 25% POLYETHYLENE GLYCOL (PEG) SOLUTION AND REPEATED ON THE E801 ANALYZER. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E801 ANALYZER AND AN E411 ANALYZER ON (B)(6)2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884657 ↗
• MalfunctionMar 8, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY ON A COBAS 8000 E801 MODULE. THE SAMPLES ALSO HAD DISCREPANT RESULTS WHEN TESTED ON ANOTHER COBAS 8000 E801 MODULE AND A COBAS E411 IMMUNOASSAY ANALYZER. REFER TO THE ATTACHMENT FOR THE PATIENTS' DATA. SAMPLE 1 WAS INITIALLY TESTED ON THE CUSTOMER'S E801 MODULE ON (B)(6) 2024 AND SAMPLE 2 WAS INITIALLY TESTED ON THE CUSTOMER'S E801 MODULE ON (B)(6) 2024. THE SAMPLES WERE PROVIDED FOR INVESTIGATION WHERE THEY TESTED ON AN E411 ANALYZER ON (B)(6) 2024 AND A 2ND E801 MODULE ON (B)(6) 2024. THE SAMPLES WERE ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18870596 ↗
• MalfunctionMar 7, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS FT3 III VER.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2024: THE INITIAL FT3 RESULT FROM THE ANALYZER WAS 11.3 PG/ML. THE INITIAL RESULT WAS QUESTIONED BY THE ENDOCRINOLOGIST AS IT WAS DEEMED HIGH AND DID NOT FIT THE CLINICAL PICTURE AND THE TSH AND FT4 RESULTS OF THE PATIENT, PROMPTING THE RERUN OF THE PATIENT SAMPLE. ON (B)(6) 2024: THE FIRST FT3 REPEAT RESULT FROM ANOTHER E 801 ANALYZER WITH THE PATIENT SAMPLE IN A HITACHI CUP WAS 9.2 PG/ML. THE SERUM SAMPLE TUBE WAS TREATED WITH A SERUM SEPARATOR (VALVE FILTER) BEFORE THE FOLLOWING RERUNS: THE SECOND REPEAT RESULT FROM THE ANALYZER WAS 9.32 PG/ML. THE THIRD REPEAT RESULT FROM THE ANALYZER WAS 9.38 PG/ML. THE FOURTH REPEAT RESULT FROM THE ANALYZER WAS 9.48 PG/ML. THE RESULT OF 9.2 PG/ML OR 9.3 PG/ML WAS CONFIRMED. THE REPORTER SUSPECTED INTERFERENCE IN THE PATIENT SAMPLE AND WOULD LIKE TO KNOW IF FT3 RESULTS WOULD DECREASE AFTER TREATMENT WITH A SERUM SEPARATOR (VALVE FILTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855852 ↗
• MalfunctionJan 24, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574585 ↗
• MalfunctionJan 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON TWO COBAS E 801 MODULES AND A COBAS E 411 IMMUNOASSAY ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502536 ↗