ARCHITECT 7K65-39Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740119812), received between Mar 4, 2024 and Sep 29, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930571 ↗
• MalfunctionJun 23, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED FREE T4 REFERENCE RANGE: 10 - 24 PMOL/L): (B)(6) 2026, SID (B)(6), INITIAL RESULT = 35.3 PMOL/L, REPEAT RESULT = 18.7 PMOL/L; (B)(6) 2026, SID (B)(6), INITIAL RESULT = 27.7 PMOL/L, REPEAT RESULT = 14.9 PMOL/L; (B)(6) 2026, SID (B)(6), INITIAL RESULT = 28.3 PMOL/L, REPEAT RESULT = 21.8 PMOL/L; (B)(6) 2026, SID (B)(6), INITIAL RESULT = 30.4 PMOL/L, REPEAT RESULT = 22.2 PMOL/L; SID (B)(6), INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 22.6 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593903 ↗
• MalfunctionMay 20, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 (FT4) RESULTS ON MULTIPLE ARCHITECT PROCESSING MODULE FOR MULTIPLE PATIENTS. THE PATIENTS WERE IN THE HOSPITAL DUE TO HEART DISEASE. THE RESULT PROVIDED WERE: ON (B)(6) 2024 ,FIRST PATIENT SID (B)(6) , FT4 INITIAL= 1.68 NG/DL /REPEATED ON ARCHITECT (B)(6) =0.86 AND 0.83 NG/DL. ON (B)(6) 2024 ,SECOND PATIENT SID (B)(6), FT4 INITIAL=>5.00 NG/DL /REPEATED ON ARCHITECT ISR62760=0.97 AND 0.95 NG/DL. THE CUSTOMER STATED THE PATIENTS UNDERWENT FOR CARDIAC CATHETERIZATION DUE TO THE PATIENT'S CURRENT CONDITION. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351244 ↗
• MalfunctionApr 25, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS ON TWO PATIENTS THAT WERE NOT REPORTED OUT OF THE LAB. THE FOLLOWING RESULTS WERE PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 0.70 TO 1.48 NG/ML): 65 YEAR OLD: SID (B)(6) , INITIAL RESULT = 2.89 NG/DL, REPEATS = 1.58 NG/DL AND 1.40 NG/ML ADDITIONAL LABORATORY DATA WAS PROVIDED: TSH = 2.08 UIU/ML 86 YEAR OLD: SID (B)(6) , INITIAL RESULT = 3.70 NG/DL, REPEATS = 2.13 NG/DL, 1.48 NG/DL, AND 1.32 NG/DL ADDITIONAL LABORATORY DATA WAS PROVIDED: TSH = 1.94 UIU/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180972 ↗
• MalfunctionMar 4, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0.70-1.48 NG/DL): (B)(6) 2024 SAMPLE ID (B)(6) INITIAL RESULT ON ANALYZER (B)(6) = 3.12 NG/DL, REPEAT ON SAME ANALYZER = 1.46 NG/DL. SAMPLE ID (B)(6) INITIAL RESULT ON ANALYZER (B)(6) = 1.7 NG/DL, REPEAT RESULT ON ANALYZER (B)(6) = 1.33 NG/DL. SAMPLE ID (B)(6) INITIAL RESULT ON ANALYZER (B)(6) = 1.43 NG/DL, REPEAT ON ANALYZER (B)(6) = 0.95 NG/DL. SAMPLE ID (B)(6) INITIAL RESULT ON ANALYZER (B)(6) = 1.83 NG/DL, REPEAT ON ANALYZER (B)(6) = 1.25 NG/DL. SAMPLE ID (B)(6) INITIAL RESULT ON ANALYZER (B)(6) = 1.54 NG/DL, REPEAT RESULT ON ANALYZER (B)(6) = 1.17 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18831879 ↗