Elecsys FT4 IV 09043284190Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 07613336172780), received between Nov 14, 2022 and Sep 28, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “High Test Results” (30 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 45 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 50917886 ↗
• MalfunctionMar 13, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. APPROXIMATELY 30 SAMPLES HAD AN INITIAL FT4 RESULT > 20 NG/L. WHEN REPEATED, THE RESULT WAS WITHIN THE NORMAL RANGE. ONE EXAMPLE WAS PROVIDED OF AN INITIAL RESULT OF 25.3 NG/L, AND A REPEAT RESULT OF 10.8 NG/L. AN ESTIMATED EXAMPLE WAS AN INITIAL RESULT OF 25 NG/L., AND A REPEAT RESULT OF 8 NG/L. THE SAMPLES WERE REPEATED ON THE SAME ANALYZER OR ON ANOTHER COBAS PRO ANALYZER AT THE CUSTOMER SITE. THE LOWER (REPEAT) RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE CONSISTENT WITH THE PATIENTS' HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598672 ↗
• MalfunctionJan 26, 2026High Test Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV RESULTS FOR: 2 PATIENT SAMPLE FROM A COBAS E 801 ANALYTICAL UNIT 3 PATIENT SAMPLES FROM THE COBAS 8000 CORE UNIT AND A COBAS E 801 ANALYTICAL UNIT. 5 PATIENT SAMPLE FROM A COBAS 8000 CORE UNIT. 2. PATIENT AGE RANGE: 22-66 YEARS, 1-ASKU, 3. PATIENT WEIGHT RANGE: ASKU, 4. PATIENT SEX BREAKDOWN: 3-FEMALE, 7-MALE, 5. PATIENT RACE BREAKDOWN: 1-ASIAN, 9-ASKU, 6. PATIENT ETHNICITY BREAKDOWN: 1-NON-HISPANIC/LATINO, 9-ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183960 ↗
• 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 FT4 IV 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 FT3 III 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 23866292 ↗
• MalfunctionNov 26, 2025Signal Artifact/Noise; High Test Results; Signal Artifact/Noise; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV ASSAY RESULTS WITH TWO SAMPLES FROM ONE PATIENT TESTED ON A COBAS E 801 ANALYTICAL UNIT WHEN COMPARED TO A COMPETITOR TEST. SAMPLE 1 (B)(6) 2025): THE RESULT USING THE ARCHITECT ASSAY WAS 1.37 NG/DL. THE RESULT USING THE E801 WAS 2.32 NG/DL. ON (B)(6) 2025, ANTI-T4 ANTIBODIES WERE DETERMINED AND WERE NEGATIVE. THE SAMPLE WAS INCUBATED WITH MICROPARTICLES FOR THE STUDY OF STREPTAVIDIN AND BIOTIN INTERFERENCE; THE RESULT WAS FT4: 2.42 NG/DL. THE SAMPLE WAS ALSO TREATED WITH HBR SCANTIBODIES TUBES TO ELIMINATE INTERFERENCE FROM HETEROPHILE ANTIBODIES; THE RESULT WAS FT4: 2.40 NG/DL. SAMPLE 2 (B)(6) 2025): THE RESULT USING THE E801 WAS 2.41 NG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655732 ↗
• MalfunctionOct 23, 2025Low Test Results; Low Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV ASSAY RESULTS FOR 7 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR ASSAY. 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 23369459 ↗
• MalfunctionOct 23, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT NOT MATCHING THE PATIENT'S CLINICAL HISTORY WHEN TESTED FOR ELECSYS FT4 IV ON A COBAS E 801 ANALYTICAL UNIT AND COMPARED TO A DIFFERENT COBAS 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 23369426 ↗
• MalfunctionApr 29, 2025Low Test Results; Low Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 402 ANALYTICAL UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925237 ↗
• MalfunctionApr 29, 2025High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 2 PATIENT SAMPLES TESTED WITH ELECSYS FT4 IV ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: 76 YEAR, 1 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 21925235 ↗
• MalfunctionApr 29, 2025Incorrect Measurement; Chemical Problem; Incorrect Measurement; Chemical Problem

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV 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 21925113 ↗
• MalfunctionJan 30, 2025False Positive Result; False Positive Result

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF NON-REPRODUCIBLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT4 IV 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 21275923 ↗
• MalfunctionJan 29, 2025High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THERE WERE ALLEGATIONS OF QUESTIONABLE HIGH RESULTS FOR 3 PATIENT SAMPLES TESTED FOR ELECSYS FT4 IV ON 1 COBAS E801 ANALYTICAL UNIT AND 2 COBAS 8000 E 602 MODULES. 2. PATIENT AGE RANGE: ONE 85 YEARS, 2 ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 1 FEMALE, 2 ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266840 ↗
• MalfunctionJan 29, 2025Low Test Results; Low Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT4 IV ON A COBAS E801 ANALYTICAL UNIT WHEN COMPARED TO A SIEMENS (CLIA) ANALYZER. 2. PATIENT AGE RANGE: 41 YEARS OLD. 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 21266829 ↗
• MalfunctionJan 29, 2025Non Reproducible Results; Non Reproducible Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS NOT MATCHING THE PATIENT'S CLINICAL STATUS FOR 1 PATIENT TESTED FOR ELECSYS FT4 IV ON A COBAS E801 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 21266813 ↗
• MalfunctionOct 25, 2024Non Reproducible Results; Non Reproducible Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV RESULT FOR ONE PATIENT FROM THE COBAS E 801 MODULE. 2. PATIENT AGE RANGE: ASKU. 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 20538151 ↗
• MalfunctionOct 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV RESULTS FOR ONE PATIENT FROM A COBAS E 801 MODULE 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 20535417 ↗
• MalfunctionOct 25, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT TESTED FOR ELECSYS FT4 III ON A COBAS 8000 E 801 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 20534259 ↗
• MalfunctionApr 29, 2024High Test Results; High Test Results

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH ELECSYS FT4 IV 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 19202595 ↗
• 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 FT4 IV. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III 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 19153802 ↗
• MalfunctionMar 5, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III V2, ELECSYS FT4 III AND ELECSYS FT4 IV RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS 8000 CORE UNIT AND THE INVESTIGATION LABORATORY'S COBAS E 801 MODULE. THE REPORTER STATED THAT THEY SUSPECTED STREPTAVIDIN INTERFERENCE. THE REPORTER STATED THEY NOTED THE QUESTIONABLE RESULTS WHEN THEY RERAN THE PATIENT SAMPLE ON THEIR WAKO ACCURASEED AND ABBOTT ALINITY ANALYZERS AND THAT THEY SUSPECTED STREPTAVIDIN INTERFERENCE. THE PATIENT SAMPLE WAS THEN SENT TO THE INVESTIGATION LABORATORY FOR FURTHER ANALYSIS. THIS MDR IS FOR THE FT4 IV ASSAY. PLEASE REFER TO: MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT4 III ASSAY. MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT3 III ASSAY. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836518 ↗
• MalfunctionMar 1, 2024High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT3 III (FT3 III), AND ELECSYS FT4 IV (FT4 IV) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. THIS MEDWATCH WILL COVER FT4 IV. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS. ON (B)(6) 2024 THE FT3 III RESULT FROM THE E801 ANALYZER WAS 22.1 PG/ML. ON (B)(6) 2024 THE FT4 IV RESULT FROM THE E801 ANALYZER WAS 6.68 NG/DL. THE PATIENT WAS MOVED TO A DIFFERENT HOSPITAL. ON (B)(6) 2024 THE THYROID RESULTS FROM THE OTHER HOSPITAL WERE "NORMAL." DUE TO THE "NORMAL" RESULTS FROM THE OTHER HOSPITAL, THE CUSTOMER SENT THE PATIENT SAMPLE TO AN EXTERNAL LABORATORY FOR TESTING BY A COMPETITOR METHOD. ON (B)(6) 2024 THE FT3 RESULT FROM THE COMPETITOR METHOD WAS 3.7 PG/ML. ON (B)(6) 2024 THE FT4 RESULT FROM THE COMPETITOR METHOD WAS 1.5 NG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18817621 ↗
• MalfunctionFeb 28, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH V2 (TSH V2), ELECSYS FT4 III AND ELECSYS FT4 IV RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS 8000 CORE UNIT AND THE INVESTIGATION LABORATORY'S COBAS E 801 MODULE. THE REPORTER STATED THAT THEY SUSPECT SOME NON-SPECIFIC INTERFERENCE IN ELECSYS THYROID ASSAYS. THE PATIENT SAMPLE WAS RERUN ON WAKO ACCURASEED AND ABBOTT ALINITY ANALYZERS. IT WAS ALSO SENT TO AN INVESTIGATION LABORATORY THAT USES A COBAS E 801 MODULE. THIS MDR IS FOR THE FT4 IV ASSAY. PLEASE REFER TO: MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE TSH V2 ASSAY. MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT4 III ASSAY. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796442 ↗
• MalfunctionDec 14, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III VER.2, ELECSYS FT4 III ASSAY AND ELECSYS FT4 IV ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS 8000 CORE UNIT AND THE INVESTIGATION SITE'S COBAS E 801 MODULE. THIS MDR IS FOR THE FT4 IV ASSAY. PLEASE REFER TO MEDWATCH WITH: A1. PATIENT IDENTIFIER (B)(6) FOR THE FT3 III ASSAY. A1. PATIENT IDENTIFIER (B)(6) FOR THE FT4 III ASSAY. THE REPORTER SUSPECTS INTERFERENCE WITH T3 MONOCLONAL ANTIBODIES. THE PATIENT SAMPLE WAS RERUN ON THE CUSTOMER'S WAKO ACCURASEED AND ABBOTT ALINITY. THE PATIENT SAMPLE WAS ALSO SENT TO THE INVESTIGATION SITE FOR RERUNS. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327471 ↗
• MalfunctionNov 14, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III AND ELECSYS FT4 IV RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 MODULE, AND THE INVESTIGATION SITE'S COBAS E 801 AND COBAS E 411 MODULES. THIS MDR IS FOR THE FT4 IV ASSAY. PLEASE REFER TO MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT3 III ASSAY. THE DATE THE INFORMATION WAS RECEIVED WAS USED AS THE DATE OF THE EVENT. THE PATIENT SAMPLE WAS SENT TO THE INVESTIGATION SITE THAT USES A COBAS E 801 AND AN E 411 AND AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT; DISCREPANT RESULTS WERE NOTED. PLEASE REFER TO THE ATTACHMENT IN THE MEDWATCH (B)(6) FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129779 ↗
• MalfunctionNov 14, 2023High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT4 G4 (FT4 IV) ASSAY AND FT3 G3 (FT3 III) ASSAY ON A COBAS 8000 E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO A COMPETITOR'S (ABBOTT) METHOD. THIS MEDWATCH WILL APPLY TO THE FT4 IV ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 III ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS FOR FT4 IV AND FT3 III.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129340 ↗