ARCHITECT 7K65-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00380740119805), received between Feb 12, 2024 and Nov 18, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “High Test Results” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR TWO PATIENTS. UPON REPEAT TESTING, LOWER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 (15-YEAR-OLD FEMALE): SID (B)(6): INITIAL ARCHITECT FREE T4 RESULT = >5.0 NG/DL REPEAT RESULT = 1.24 NG/DL. PATIENT 2: INITIAL ARCHITECT FREE T4 RESULT = 2.40 NG/DL REPEAT RESULT = 0.85 NG/DL. PER THE ARCHITECT FREE T4 PACKAGE INSERT, THE NORMAL RANGE IS 0.70 NG/DL TO 1.48 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583872 ↗
• MalfunctionJul 15, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT FREE T4 RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A 37-YEAR-OLD MALE PATIENT. THE RESULT WAS INCONSISTENT WITH ANOTHER SAMPLE COLLECTED ON THE SAME DAY. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 AT 12:02 SID: (B)(6) RESULT = 0.84 NG/DL. (B)(6) 2025 AT 13:00 SID: (B)(6) RESULT = 0.67 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505467 ↗
• MalfunctionApr 28, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9 ¿19 PMOL/L): (B)(6), (B)(6) 2025, INITIAL FT4 RESULT= 43.42 PMOL/L; (B)(6) 2025, REPEAT RESULT= 15.96 PMOL/L, 14.43 PMOL/L, 13.41 PMOL/L, 14.00 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917930 ↗
• MalfunctionApr 2, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 FOR A (B)(6)-YEAR-OLD MALE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL RESULT >5 NG/DL; REPEAT RESULT= 1.01 NG/DL; 2020 TEST HISTORY, INITIAL AND REPEAT RESULT >5 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752184 ↗
• MalfunctionMar 10, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE PATIENT. THE SAMPLE WAS RETESTED AT A REFERENCE LAB WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), ARCHITECT RESULT = 21 AND REPEAT = 50 PMOL/L. REFERENCE LAB (JOHN RADCLIFE) = 16 PMOL/L. APPROXIMATE REFERENCE RANGE = 9-19.1 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561106 ↗
• MalfunctionJan 30, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR THREE PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE 0.78-1.48 NG/DL). ON (B)(6) 2024, SID (B)(6), INITIAL RESULT = 1.50 NG/DL, REPEAT RESULT = 1.30NG/DL. ADDITIONAL LAB RESULT PROVIDED: TSH RESULT = 2. TSH RESULT = 15 UIU/ML, NO REPEAT RESULT PROVIDED. ON (B)(6) 2024, SID (B)(6), INITIAL RESULT = 1.59 NG/DL, REPEAT RESULT = 1.26NG/DL ADDITIONAL LAB RESULT PROVIDED: TSH RESULT = 2.39 UIU/ML, NO REPEAT RESULT PROVIDED. ON (B)(6) 2024, SID (B)(6), INITIAL RESULT = 1.59 NG/DL, REPEAT RESULT = 1.19NG/DL. ADDITIONAL LAB RESULT PROVIDED: TSH RESULT =1.39 UIU/ML, NO REPEAT RESULT PROVIDED NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276864 ↗
• MalfunctionSep 25, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR A 66 YEAR OLD FEMALE PATIENT. ADDITIONALLY, THE CUSTOMER NOTED AN ELEVATED IMPRESSION WITH THE QUALITY CONTROLS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.2 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306140 ↗
• MalfunctionSep 24, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR A 73-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED FROM TWO SAMPLES, SAMPLE ID (B)(6), FOR THIS PATIENT: INITIAL RESULT, ON (B)(6)2024, WAS >64.35, REPEAT RESULTS WERE 24.3, >64.35, AND >64.35 PMOL/L, REPEAT RESULTS, ON (B)(6)2024, WERE 15.5 AND 17.01 PMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER, SERIAL NUMBER (B)(6), AND THE RESULTS WERE >64.35, >64.35, AND >64.35 PMOL/L, REPEAT RESULTS, ON (B)(6)2024, WERE 19.65, 14.15 AND 14.94 PMOL/L. THE PATIENT HAD AN EDTA PLASMA SAMPLE THAT WAS TESTED, AND THE RESULT WAS 13.81, REPEAT, ON THE OTHER ANALYZER, SERIAL NUMBER (B)(6), WAS 13.83 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294418 ↗
• MalfunctionAug 26, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCREPANT ARCHITECT FREE T4 RESULTS ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2024: INITIAL TEST (SERUM): 1.69 NG/DL. RE-TEST AFTER RE-CENTRIFUGATION (SERUM): > 5.00 NG/DL. RE-TEST AFTER RE-CENTRIFUGATION (SERUM): 2.93 NG/DL . RE-TEST WITH EDTA PLASMA: 1.17 NG/DL. RE-TEST AFTER TRANSFERRING TO HIGH-SPEED COAGULATION BLOOD COLLECTION TUBE: 2.20 NG/DL. RE-TEST AFTER CENTRIFUGATION AT 4000 RPM FOR 15 MINUTES: 2.43 NG/DL . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062914 ↗
• MalfunctionAug 15, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. THE SAMPLE WAS REPEATED ON ANOTHER ARCHITECT WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT PROCESSED ON (B)(6) 2024 = 1.55 NG/DL(RAN ON (B)(6)). REPEAT RESULT PROCESSED ON (B)(6) 2024 = 1.26 NG/DL(RAN ON (B)(6)). REFERENCE RANGE = 0.70 TO 1.48 NG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991823 ↗
• MalfunctionJul 22, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID: (B)(6), INITIAL TEST > 5.0 NG/DL; REPEAT RESULT= 2.41 NG/DL. ADDITIONAL INFORMATION WAS PROVIDED: TSH= 1.066 UIU/ML; TSH 1:5 DILUTION= 1.371 UIU/ML; FT3= 1.81 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795140 ↗
• MalfunctionJun 20, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2024 = > 5.0 / 1.7. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19577685 ↗
• MalfunctionJun 9, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A FEMALE PATIENT. THE SAMPLE WAS REPEATED ON ANOTHER INSTRUMENT WHICH GENERATED A NORMAL RESULT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER'S NORMAL RANGE: 0.70 NG/DL TO 1.48 NG/DL (B)(6) 2024 SID (B)(6) INITIAL RESULT = 1.79 NG/DL REPEAT RESULT ON ANOTHER INSTRUMENT (I1SR07056) = 0.97 NG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495254 ↗
• MalfunctionMay 28, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 (FT4) FOR ONE PATIENT NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGES; FT4= 9-19 PMOL; TSH= 0.4-5.0 UIUI/ML): (B)(6) 2024, SID (B)(6) INITIAL FT4= >64.35 PMOL/L; REPEAT FT4= 26.2 PMOL.L; NEW SAMPLE FT4= 17.73 PMOL/L. ADDITIONAL DATA WAS PROVIDED, INITIAL TSH= 7.55 UIU/ML; REPEAT TSH= 6.9 UIU/ML; NEW SAMPLE TSH= 7.06 UIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19406694 ↗
• MalfunctionMay 15, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. THE FOLLOWING EXAMPLE WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 0.70-1.48 NG/DL): INITIAL RESULT WAS 1.94, REPEAT RESULT WAS 1.45 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326250 ↗
• MalfunctionMay 14, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR MULTIPLE SAMPLES ACROSS TWO INSTRUMENTS. THE FOLLOWING INFORMATION WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 9.0 TO 19.0 PMOL/L): (B)(6) 2024 SID (B)(6) INITIAL RESULT ((B)(6)) = 19.27 PMOL/L, REPEAT = 16.67 PMOL/L. (B)(6) 2024 SID (B)(6) INITIAL RESULT ((B)(6)) = 21.57 PMOL/L, REPEAT = 16.19 PMOL/L. (B)(6) 2024 SID (B)(6) INITIAL RESULT ((B)(6)) = 22.02 PMOL/L, REPEAT = 15.81 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311275 ↗
• MalfunctionMay 7, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE IS 0.70-1.48 NG/DL) INITIAL RESULT = 1.32 NG/ML, REPEAT RESULT = 0.68 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262178 ↗
• MalfunctionApr 29, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARHCITECT I2000SR ANALYZER. THE CUSTOMER RETESTS THE FREE T4 RESULT WHEN IT EXCEEDS THE UPPER LIMIT. THE CUSTOMER SAYS IT OFTEN OCCURS IN OUTPATIENTS. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024: SAMPLE ID (B)(6): INITIAL RESULT = 2.15 NG/DL; REPEAT RESULT = 1.57 NG/DL SAMPLE ID (B)(6): INITIAL RESULT = 1.68 NG/DL; REPEAT RESULT = 1.38 NG/DL ON (B)(6)2024: SAMPLE ID (B)(6): INITIAL RESULT = 1.84 NG/DL; REPEAT RESULT = 1.58 NG/DL SAMPLE ID (B)(6): INITIAL RESULT = 1.64 NG/DL; REPEAT RESULT = 1.24 NG/DL SAMPLE ID (B)(6): INITIAL RESULT = 1.60 NG/DL; REPEAT RESULT = 1.21 NG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203550 ↗
• MalfunctionApr 12, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULT WERE PROVIDED: INITIAL RESULT >5.0 NG/DL, REPEAT RESULTS 1.7 NG/DL, 1.36 NG/DL, REPEAT RESULT ON ANOTHER ARCHITECT (B)(6) 1.40 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096116 ↗
• MalfunctionApr 1, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR FOUR PATIENTS ON ARCHITECT I2000SR, SERIAL NUMBERS (B)(6). THE RESULTS WERE LOWER WHEN THE SAMPLES WERE REPEATED. THE FOLLOWING DATA WAS PROVIDED: (B)(6): (B)(6) 2024. SAMPLE 1: INITIAL TEST: >5 NG/DL. RETEST: 1.22 NG/DL. (B)(6) 2024. INITIAL TEST: >5 NG/DL. RETEST: 1.28 NG/DL. ANOTHER DEVICE: (B)(6): SAMPLE 3: INITIAL TEST: 2.79 NG/DL. RETEST: 1.19 NG/DL. SAMPLE 4: INITIAL TEST: 2.05 NG/DL. RETEST: 1.31 NG/DL. ADDITIONAL DATA FOR TWO MORE PATIENTS PROVIDED (B)(6) 2024: 1ST SAMPLE = INITIAL RESULT = 2.37 REPEAT 1.13 NG/DL. 2ND SAMPLE = INITIAL RESULT = 2.03 REPEAT 1.21 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011422 ↗
• MalfunctionMar 18, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A PATIENT WITH CONGESTIVE CARDIAC FAILURE AND SICK SINUS SYNDROME. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE: 0.70 TO 1.48 NG/DL SID(B)(6): (B)(6) 2024 SAMPLE 1 (SERUM): INITIAL RESULT = >5.0 NG/DL; REPEAT RESULT = 1.50 NG/DL REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6)) = 1.97 NG/DL (B)(6) 2024 REPEAT RESULT AFTER RECENTRIFUGED = 1.0 NG/DL OTHER TEST RESULT PROVIDED: TSH = 2.949 ¿IU/ML (B)(6) 2024 SAMPLE 2 (SERUM): INITIAL RESULT = 2.88 NG/DL REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6)) = 1.96 NG/DL REPEAT RESULT AFTER RECENTRIFUGED = 1.16 NG/DL (B)(6) 2024 SAMPLE 3 (PLASMA): INITIAL RESULT = 1.09 NG/DL REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6)) = 1.01 NG/DL THE CUSTOMER PROVIDED THE PATIENT¿S MEDICATION WHICH INCLUDED THE FOLLOWING: ASPARA POTASSIUM TABLETS, ENSURE, MOHRUS TAPES, LIXIANA (FXA INHIBITOR, ANTICOAGULANT) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927395 ↗
• MalfunctionMar 15, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS ON A PATIENT DIAGNOSED WITH HYPOTHYROIDISM. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2023 . TSH 1.65, FT3 2.41, FT4 1.42. SID (B)(6) , ON (B)(6) 2024 , INITIAL TEST, REPEAT TEST, TSH 2.8109 UIU/ML, 3.5787 UIU/ML, FT3 2.84 PG/ML, 2.33 PG/ML, FT4 >5.00 NG/DL, 1.95 NG/DL. SID (B)(6), ON (B)(6) 2024, INITIAL TEST, REPEAT TEST, FT4 >5.00 NG/DL, 0.96 NG/DL. SID (B)(6), ON (B)(6) 2024, INITIAL TEST, REPEAT TEST, FT4 2.05 NG/DL, 1.18 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18917399 ↗
• MalfunctionMar 7, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULES FOR A PATIENT WHEN USING A SAMPLE COLLECTED IN PLASMA SEPARATING TUBE (PST). A NEW SAMPLE FROM THE PATIENT WAS COLLECTED IN EDTA TUBE AND THE RESULTS WERE LOWER. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL REFERENCE RANGE FOR ADULT: 9 TO 19 PMOL/L. (B)(6) 2024 SID (B)(6) (SAMPLE COLLECTED IN PST): ARCHITECT FREE T4 RESULT (B)(6) = 21.42 PMOL/L ARCHITECT FREE T4 RESULT (B)(6) = 43.17 PMOL/L ARCHITECT FREE T4 RESULT (B)(6) = 25.79 PMOL/L ARCHITECT FREE T4 RESULT (B)(6) = 43.99 PMOL/L ARCHITECT FREE T4 RESULT (B)(6) = 47.83 PMOL/L ARCHITECT FREE T4 RESULT (B)(6) = 61.64 PMOL/L (POST RECALIBRATION) (B)(6) 2024 SID (B)(6) (SAMPLE COLLECTED IN EDTA): ARCHITECT FREE T4 RESULT (B)(6) = 13.38 PMOL/L. ARCHITECT FREE T4 RESULT (B)(6) = 14.09 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856645 ↗
• MalfunctionFeb 14, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY INCREASED ARCHITECT FREE T4 RESULT FOR MULTIPLE PATIENTS ON ARCHITECT I2000SR, SERIAL NUMBER (B)(6). THE RESULTS WERE NOT REPORTED OUT. THE SAMPLES WERE REPEATED ON OTHER ARCHITECT I2000SRS, SERIAL NUMBERS (B)(6), WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT FROM (B)(6) = 1.64 REPEAT RESULT FROM (B)(6) = 1.42 DIFFERENCE OF 15.49%. SID (B)(6) INITIAL RESULT FROM (B)(6) = 1.51 REPEAT RESULT FROM (B)(6) = 1.34 DIFFERENCE OF 12.69%. SID (B)(6) INITIAL RESULT FROM (B)(6) = 1.62 REPEAT RESULT FROM (B)(6) = 1.47 DIFFERENCE OF 10.20%. SID (B)(6) INITIAL RESULT FROM (B)(6) = 1.72 REPEAT RESULT FROM (B)(6) = 1.47 DIFFERENCE OF 17.01%. SID (B)(6) INITIAL RESULT FROM (B)(6) = 1.65 REPEAT RESULT FROM (B)(6) = 1.30 DIFFERENCE OF 26.92%. SID (B)(6) INITIAL RESULT FROM (B)(6) = 1.57 REPEAT RESULT FROM (B)(6) = 1.36 DIFFERENCE OF 15.44%. SID (B)(6) INITIAL RESULT FROM (B)(6) = 1.60 REPEAT RESULT FROM (B)(6) = 1.44 DIFFERENCE OF 11.11%. SID (B)(6) INITIAL RESULT FROM (B)(6) = 1.51 REPEAT RESULT FROM (B)(6) = 1.25 DIFFERENCE OF 20.80%. SID (B)(6) INITIAL RESULT FROM (B)(6) = 1.63 REPEAT RESULT FROM (B)(6) = 1.36 DIFFERENCE OF 19.85%. S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702908 ↗
• MalfunctionFeb 12, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. THE INITIAL RESULT WAS 32.17 PMOL/L, RECHECK RESULT WAS 17.66 PMOL/L (REFERENCE RANGE: 9.01-19.05 PMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691431 ↗