ARCHITECT 7K65-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00380740119799), received between Mar 15, 2024 and Sep 28, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “High Test Results” (36 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026High Test Results

  A literature review article by Suzuki, T., Ohba, et al. ¿Spuriously Elevated Free Thyroxine Due to Fibrin Interference in a Patient Receiving Apixaban: A Case Report and Literature Review¿ Internal Medicine. 2026; 65(15):2112-2117. DOI: 10.2169/internalmedicine.6473-25, documented a case study of a 79-year-old female patient with a history of chronic thyroiditis and atrial fibrillation, which was being treated with apixaban once a day. Beginning in 2023, mid December, the patient had routine blood testing with falsely elevated ARCHITECT Free T4. The following results were provided:Mid December 2023, Free T4 result (serum)= >5.00 ng/dL.Late December 2023, Free T4 result (serum)= 2.54 ng/dL.Mid February 2024, Free T4 result (serum)= >5.00 ng/dL; repeat result (plasma)= 0.89 ng/dL.Early October 2024, Free T4 result (plasma)= 1.03 ng/dL.Reference range 1.00-1.70 ng/dL.The patient had a cervical ultrasound performed of which showed mild heterogenous, low-echoic internal echoes in the left thyroid lobe. There was no additional impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916310 ↗
• MalfunctionAug 17, 2026High Test Results

  The customer observed falsely elevated ARCHITECT Free T4 results for a 30-year-old female patient. The following data was provided (Customer¿s normal range is 0.70-1.48 ng/dL):Sample ID 300178100007 initial result, on 30JUL2026, was 1.64, repeat results were 1.43, 1.47, and 1.50 ng/dL. Additional results were provided: Free T3 initial result was 2.47, repeat results were 2.34, 2.39, and 2.41 pg/mL; TSH initial result was 29.74, repeat results were 38.76, 39.09, and 38.74 uIU/mL. There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280800 ↗
• MalfunctionJan 26, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE FEMALE PATIENT IN HER EIGHTIES WHO IS NOT ON ANY THYROID TREATMENT WHEN COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: PATIENT ARCHITECT RESULTS FROM (B)(6) 2025: FT4 2.10 NG/DL. OTHER RESULTS = FT3 2.75 PG/ML TSH 3.16 UIU/ML. PATIENT RESULTS FROM ANOTHER METHOD(CLEIA): FT4 0.97 NG/DL. OTHER RESULTS = FT3 2.60 PG/ML TSH 7.10 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180122 ↗
• MalfunctionDec 23, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR A 47-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 0.700-1.480 NG/DL) SAMPLE ID (B)(6) INITIAL RESULT WAS >5.00, REPEAT RESULT WAS 1.19 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881825 ↗
• MalfunctionDec 4, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE (B)(6) YEAR OLD MALE PATIENT WITH PRE-EXISTING HEART FAILURE IN STABLE CONDITION. THE PATIENT¿S FT4 WAS LOWER WITH ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 ARCHITECT RESULTS = >5.00 AND >5.00 NG/DL USING REAGENT LOT 73547UD00. (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00. (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00. (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00. TREATMENT: POTASSIUM IODIDE PRESCRIPTION STARTING (B)(6) 2025. NORMAL REFERENCE RANGE = FT4 0.70-1.48NG/DL. (B)(6) 2025 RECEPTOR ANTIBODY, THYROGLOBULIN ANTIBODY, TPO ANTIBODY: NORMAL. RESULTS OF OUTSOURCED TESTING (1STEP METHOD) FT4: 1.25 NG/DL. ADDITIONAL DATA PROVIDED 02DEC2025: REFERENCE LAB RESULTS: REPRODUCIBILITY TEST: FT4 (NG/DL) 1.02. ADDITION OF HETEROPHILE ANTIBODY BLOCKERS FOR FT4 DID NOT RESULT IN A SIGNIFICANT DECREASE IN THE MEASURED VALUES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717178 ↗
• MalfunctionDec 4, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE (B)(6) MALE PATIENT WITH PRE-EXISTING HEART FAILURE IN STABLE CONDITION. THE PATIENT¿S FT4 WAS LOWER WITH ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 ARCHITECT RESULTS = >5.00 AND >5.00 NG/DL USING REAGENT LOT 73547UD00. (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00. (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00. (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00. TREATMENT: POTASSIUM IODIDE PRESCRIPTION STARTING (B)(6) 2025. NORMAL REFERENCE RANGE = FT4 0.70-1.48NG/DL. (B)(6) 2025 AND (B)(6) 2025 RECEPTOR ANTIBODY, THYROGLOBULIN ANTIBODY, TPO ANTIBODY: NORMAL. RESULTS OF OUTSOURCED TESTING (1STEP METHOD). FT4: 1.25 NG/DL. ADDITIONAL DATA PROVIDED (B)(6) 2025: REFERENCE LAB RESULTS: REPRODUCIBILITY TEST: FT4 (NG/DL) 1.02. ADDITION OF HETEROPHILE ANTIBODY BLOCKERS FOR FT4 DID NOT RESULT IN A SIGNIFICANT DECREASE IN THE MEASURED VALUES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717149 ↗
• MalfunctionNov 26, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4. THE CUSTOMER REPORTED RESULTS OVER THE UPPER LIMIT AND WHEN REPEATED THE RESULTS WERE WITHIN NORMAL RANGE. (CUSTOMER REFERENCE RANGE: FREE T4 REFERENCE RANGE 0.7¿1.48). THE CUSTOMER FURTHER REPORTED THIS ALSO INCLUDED A SAMPLE FROM A MALE PATIENT NOT RECEIVING THYROID TREATMENT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: THE CUSTOMER PROVIDED FURTHER INFORMATION ON (B)(6) 2025: THE CUSTOMER REPORTED THAT THEY INCORRECTLY MADE THE BUFFER SOLUTION WITHOUT ADDING CONCENTRATED DILUTION BUFFER. THE CUSTOMER DOES NOT BELIEVE THAT THE PATIENT RESULTS ISSUE AND CONTROLS ISSUE WAS DUE TO AN ABBOTT DEVICE BUT RATHER THE CUSTOMER BELIEVES THAT THIS EVENT WAS CAUSED BY THE INCORRECTLY MADE BUFFER SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662193 ↗
• MalfunctionOct 7, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE 37-YEAR-OLD MALE PATIENT. THE SAMPLE WAS REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), PROCESSED ON (B)(6) 2025 INITIAL RESULT = >64.35 PMOL/L REPEATED ON (B)(6) 2025 = 12.2/12.2/12.7 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23238202 ↗
• MalfunctionAug 4, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE FEMALE PATIENT IN HER 80'S WITH THYROID CANCER POST-SURGERY TO REMOVE CANCER. THE PATIENT WAS ON THYRADIN. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) PROCESSED ON (B)(6) 2025: FT4 >5.00, OTHER RESULTS: FT3 5.60 TSH 1.044. PATIENT STOPPED TAKING THYRADIN AND WAS RETESTED ON (B)(6) 2025: FT4 1.02, OTHER RESULTS: FT3 2.00 TSH 1.112. RESULTS FOR PATIENT ON (B)(6) 2025: FT4 2.22, OTHER RESULTS: FT3 2.37 TSH 0.61 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22704630 ↗
• MalfunctionAug 1, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT GENERATED BY THE ARCHITECT I1000SR PROCESSING MODULE FOR A 56-YEAR-OLD FEMALE PATIENT, WHICH WAS QUESTIONED BY THE PHYSICIAN. THE SAME SAMPLE WAS REPEATED, AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 0.7 TO 1.48 NG/DL. SID (B)(6): (B)(6) 2025 INITIAL RESULT = 3.59 NG/DL, (B)(6) 2025 REPEAT RESULT = 1.13 NG/DL, RESULT FROM ANOTHER LAB (ARCHITECT PLATFORM) = 1.13 NG/DL, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687419 ↗
• MalfunctionJul 22, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (EXPECTED VALUE = 0.70 - 1.48 NG/DL): FREE T4 1.50 NG/DL, REPEATED 1.10 / 1.12 / 1.16 NG/DL. OTHER RESULTS PROVIDED: TSH: 1.5784 UIU/ML (EXPECTED VALUE = 0.35 - 4.94 IU/ML) FREE T3: 3.05 PG/ML (EXPECTED VALUE = 1.58-3.91 PG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568211 ↗
• MalfunctionJun 30, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSE ELEVATED ARCHITECT FREE T4 ON A PATIENT, 78-YEAR-OLD MALE.SID (B)(6) GENERATED ARCHITECT FREE T4 OF 2.29 NG/DL THAT REPEATED AFTER CENTRIFUGATION 1.20 NG/DL. ADDITIONAL TESTING WAS TSH 1.27, 1.28 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366193 ↗
• MalfunctionApr 22, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = >64.4 / 19.3 PMOL/L; NEW SAMPLE = 17.4 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881369 ↗
• MalfunctionFeb 7, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0.70 NG/DL TO 1.45 NG/DL): SAME PATIENT SAMPLE WAS EXTRACTED INTO 3 SAMPLES AND RESULTS GENERATED AS FOLLOWS: ON (B)(6) 2025 SAMPLE 1 INITIAL RESULT = 1.63 NG/DL, REPEAT RESULTS = 1.70 NG/DL, 1.38 NG/DL, 1.43 NG/DL, 1.54 NG/DL, REPEAT RESULTS OBTAINED BY TECHNICAL SUPPORT = 1.41 NG/DL, 1.49 NG/DL. ON (B)(6)2025 SAMPLE 2 RESULTS = 1.56 NG/DL, 1.72 NG/DL, REPEAT RESULTS OBTAINED BY TECHNICAL SUPPORT = 1.42 NG/DL, 1.56 NG/DL. SAMPLE 3 RESULTS = 1.51 NG/DL, 1.47 NG/DL, REPEAT RESULTS OBTAINED BY TECHNICAL SUPPORT = 1.46 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332812 ↗
• MalfunctionJan 30, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR MULTIPLE SAMPLES. THIS WAS IDENTIFIED AFTER A POSITIVE SHIFT IN QUALITY CONTROLS WAS SEEN. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 24.59, REPEAT = 15.93, REPEATS AFTER RECALIBRATION = 15.06 AND 16.17 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21279914 ↗
• MalfunctionJan 16, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ARCHITECT FREE T4 FOR ONE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE FT4 0.70-1.48 NG/DL): SID (B)(6), (B)(6)2024, INITIAL FT4 RESULT <0.40 NG/DL; (B)(6)2024, REPEAT FT4 RESULT= 0.85 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170584 ↗
• MalfunctionDec 20, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 (FT4) RESULTS ON ONE PATIENT. THE RESULT PROVIDED WERE: ON (B)(6)2024 SID (B)(6) FT4 INITIAL=3.07 NG/DL /REPEATED=1.19 NG/DL AND 1.04 NG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20990594 ↗
• MalfunctionDec 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A LITERATURE ARTICLE BY ANGELA D BURNS, CHRISTINA KANONIDOU, AND JANE MCNEILLY, ¿MISLEADING THYROID FUNCTION TESTS IN CONGENITAL DYSFIBRINOGENEMIA¿, ANNALS OF CLINICAL BIOCHEMISTRY 2024; 61.6: 474-479, DOCUMENTED IMPRECISE ARCHITECT FREE T4 RESULTS FOR 6 PATIENTS DIAGNOSED WITH CONGENITAL DYSFIBRINOGENEMIA. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 (89-YEAR-OLD FEMALE WITH A HISTORY OF GRAVES¿ DISEASE AND THYROID EYE DISEASE): TSH RESULT = 8.18 MU/L (REFERENCE RANGE IS 0.35 TO 5.00 MU/L), FREE T4 = 12.1 PMOL/L (REFERENCE RANGE IS 9.0 TO 21.0 PMOL/L). BASED ON THESE RESULTS, THE PATIENT¿S DAILY DOSE OF CARBIMAZOLE WAS REDUCED FROM 20 MG TO 15 MG. AFTER THE DOSE TITRATION, THE PATIENT HAD THYROID FUNCTION TESTS MEASURED ON FIVE SEPARATE OCCASIONS. IN ALL OF THESE INSTANCES THE TSH RESULTS WERE SIGNIFICANTLY ELEVATED, RANGING BETWEEN 11.2 AND 23.6 MU/L AND THE FT4 MEASURING ABOVE OR CLOSE TO THE TOP OF THE REFERENCE RANGE, WITH RESULTS BETWEEN 17.0 AND 26.5 PMOL/L. THE CLINICIANS MANAGING THE PATIENT BELIEVED THE RESULTS TO BE UNUSUAL WITH THE PATIENT DISPLAYING HYPOTHYROIDAL SYMPTOMS RATHER THAN THAT OF CENTRAL HYPERTHYROIDISM AS PREDICTED BY THE THYROID FUNCTION TEST RESULTS. A FRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20978643 ↗
• MalfunctionDec 9, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4. THE CUSTOMER ALSO REPORTED THAT THE CONTROLS TEND TO BE HIGH AS WELL. THE CUSTOMER PROVIDED THE FOLLOWING EXAMPLE DATA ON (B)(6) 2024: REFERENCE VALUE: 0.70-1.48 NG/DL SAMPLE ID (B)(6), INITIAL RESULT WAS 1.50 AND REPEAT RESULTS WERE 1.30 & 1.24. SAMPLE ID (B)(6), INITIAL RESULT WAS 1.53 AND REPEAT RESULTS WERE 1.16 & 1.07. SAMPLE ID (B)(6), INITIAL RESULT WAS 1.70 AND REPEAT RESULTS WERE 1.35 & 1.39. ADDITIONAL LABORATORY DATA PROVIDED: SAMPLE ID (B)(6), TSH WAS 2.5071 UIU/ML, FREE T3 WAS 2.68 PG/ML SAMPLE ID (B)(6), TSH WAS 1.4070 UIU/ML SAMPLE ID (B)(6), TSH WAS 0.0305 UIU/ML, FREE T3 WAS 3.83 PG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20885294 ↗
• MalfunctionNov 19, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 AND PROVIDED THE FOLLOWING EXAMPLE DATA FOR 1 SAMPLE: INITIAL RESULT WAS >5.0 AND REPEAT RESULTS WERE 1.34 & 1.29. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727256 ↗
• MalfunctionOct 16, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6): 2024 SID (B)(6)INITIAL RESULT WAS >5.00 NG/DL, 1ST REPEAT = INSTRUMENT ERROR MESSAGE 3350 UNABLE TO PROCESS MEASUREMENT ITEMS, SAMPLE PIPETTOR ASPIRATION ERROR, 2ND REPEAT = 1.27 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461660 ↗
• MalfunctionSep 23, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 0.7 TO 1.48 NG/DL): INITIAL RESULT = >5 REPEAT RESULT = 4.02 NG/DL REPEATED AGAIN AFTER HIGH SPEED CENTRIFUGE = 3 NG/DL OTHER RESULT FOR PATIENT TSH = 0.0 REPEATED X3 ALL 0.0 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278630 ↗
• MalfunctionSep 18, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 (FT4) RESULTS FOR 2 PATIENTS. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 0.70-1.48 NG/DL): 8/29:PATIENT #2: INITIAL FT4 = 1.50 NG/DL; REPEAT RESULT = 1.28 NG/DL, 8/30:PATIENT #3: INITIAL FT4 = 1.53NG/DL; REPEAT RESULT = 1.22 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250464 ↗
• MalfunctionSep 16, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. SID (B)(6) ARCHITECT FREE T4 RESULT 2.16 NG/ML, REPEATED WITH A NEW SAMPLE AND THE RESULT WAS 1.24 NG/ML (NORMAL RANGE 0.7 - 1.48 NG/DL). BECKMAN RESULT 1.40 NG/DL (NORMAL RANGE 0.59 - 1.54 NG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226098 ↗
• MalfunctionAug 27, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED PATIENT RESULTS OVER THE PAST YEAR WHEN USING THE ARCHITECT FREE T4 ASSAY. THE CUSTOMER STATED A DOCTOR POINTED OUT THAT WHILE THE FREE T4 VALUES ARE HIGH IN MANY SAMPLES, THE FREE T3 AND TSH RESULTS ARE WITHIN THE NORMAL RANGE. THE CUSTOMER PROVIDED 2 CASES THAT DEVIATED ACROSS THE REFERENCE RANGE. THE FOLLOWING DATA PROVIDED (REFERENCE RANGE FOR FREE T4: 0.70 ¿ 1.48 NG/DL): SID (B)(6): INITIAL FREE T4 RESULT = 1.334658 NG/DL; REPEAT RESULT = 1.588634 NG/DL (QUESTIONING THE HIGHER REPEAT RESULT). SID (B)(6): INITIAL FREE T4 RESULT = 1.48657 NG/DL; REPEAT RESULT = 1.023434 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20080535 ↗