ARCHITECT 3P36-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380740081317), received between Jul 31, 2017 and Dec 23, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “High Test Results” (17 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT AFP RESULTS FOR ONE PATIENT WHO DIAGNOSED WITH CANCER. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE 1.09 - 8.04 NG/ML): (B)(6) 2025 INITIAL ARCHITECT AFP RESULT FOR SID (B)(6) WAS 568.23 NG/ML, REPEATED ON (B)(6) 2025 AND THE RESULT WAS 1.42 NG/ML. THE PATIENT THEN WENT TO ANOTHER LABORATORY WHERE THE RESULT WAS REPORTED AS WITHIN NORMAL LIMITS (VALUE UNAVAILABLE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878994 ↗
• MalfunctionAug 6, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT AFP RESULT GENERATED ON THE ARCHITECT I1000SR PROCESSING FOR A PATIENT. THE SAMPLE WAS REPEATED AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER DOES NOT HAVE ANY INFORMATION REGARDING THE PATIENT¿S DIAGNOSIS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6) INITIAL RESULT = 294.14 NG/ML. (B)(6) 2024 SID (B)(6) RERUN RESULT = 5.93 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920734 ↗
• MalfunctionMay 18, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT AFP RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) 2023, SID (B)(6), INITIAL= 20.75 NG/ML /REPEATED TWICE= < 2.0 NG/ML /REPEATED ON (B)(6) 2023, =18 NG/ML /REPEATED IN 5 REPLICATES= < 2 NG/ML. LABORATORY REFERENCE RANGE FOR AFP= 0.0 TO 10 NG/ML. THE PRECISION STUDY DATA PROVIDED FOR TROUBLESHOOTING PURPOSE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954419 ↗
• MalfunctionApr 6, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT AFP RESULTS ON ONE 39YRS OLD MALE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) 2023. SID (B)(6). INITIAL= > 2000 NG/ML /REPEATED=2.22 NG/ML AND 2.19 NG/ML (REFERENCE RANGE=0.0 TO 7.0 NG/ML) ADDITIONAL INFORMATION PROVIDED: CEA=1.9; CA 19-9XR=10.5; PSA=0.4; BETA-HCG= < 1.20 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690398 ↗
• MalfunctionAug 31, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT AFP RESULTS FOR ONE PATIENT. THE INITIAL RESULT IN QUESTION FOR SID (B)(6) ON (B)(6) 2022 WAS 187.19 UI/ML. A NEW SAMPLE SID (B)(6) FROM (B)(6) 2022 GENERATED A RESULT OF >1660.00, DILUTION 1:10 >16600.00, DILUTION 1:20 18584.24 UI/ML. THE SAMPLE FROM (B)(4) 2022 (SID (B)(6)) WAS REPEATED ON (B)(6) 2022 AND THE RESULT WAS >1660.00, DILUTION 1:10 >16600.00, DILUTION 1:20 11463.05 UI/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327168 ↗
• MalfunctionMar 30, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT AFP RESULT FOR AN (B)(6) PATIENT THAT THE DOCTOR SUSPECTS HEPATOCELLULAR CARCINOMA AND IS A HCV CARRIER DUE TO OLD AGE. THE FOLLOWING DATA WAS PROVIDED ON 09MAR2021: ON (B)(6) 2020 = AFP RESULT = 28 NG/ML. ON (B)(6) 2021 = AFP RESULT = 16.17 NG/ML, REPEAT RESULT = 16.45 NG/ML. OTHER LABORATORY TESTS PERFORMED: ON (B)(6) 2021 = PIVKA II RESULT = 600 MAU/ML; ON (B)(6) 2021 = PIVKA II RESULT = 40000 MAU/ML. ON (B)(6) 2021 = CEA RESULT = 4.4 NG/ML; ON (B)(6) 2020 CEA RESULT = 3.5 NG/ML. ON (B)(6) 2021 = CA 19-9 RESULT = 36 NG/ML; ON (B)((6) 2020 CA 19-9 RESULT = 31.6. IT WAS CONFIRMED WITH THE CUSTOMER THAT BOTH MEASUREMENTS OF PIVKA-II WAS PERFORMED BY ANOTHER METHOD ((B)(4)). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590396 ↗
• MalfunctionMar 3, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE ELEVATED ARCHITECT AFP RESULT FOR A (B)(6) YEAR OLD FEMALE. THE FOLLOWING DATA WAS PROVIDED ON (B)(6) 2021: SID (B)(6) = INITIAL RESULT = 789.08 NG/ML, REPEAT RESULT = 2.04 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408450 ↗
• MalfunctionFeb 25, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT AFP RESULTS ON SEVERAL PATIENTS. THE RESULTS PROVIDED WERE: INITIAL AFP RESULT ON (B)(6) 2021/REPEATED RESULTS ON (B)(6) 2021: SID (B)(6) = 218 NG/ML / 2.98 NG/ML. SID (B)(6) =14.6 NG/ML / 2.04 NG/ML. SID (B)(6) =36.5 NG/ML / 1.36 NG/ML. SID (B)(6) =44.6 NG/ML / 1.39 NG/ML. THE COMPARISON PERFORMED FOR TROUBLESHOOTING PURPOSE AND DATA PROVIDED: SID RANGING FROM (B)(6), INITIAL AFP RESULT RANGING =0.61 NG/ML THROUGH 440.96 NG/ML/REPEATED RESULT RANGING FROM 0.61 NG/ML THROUGH 452.49 NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11380498 ↗
• MalfunctionApr 8, 2020High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED ARCHITECT AFP RESULT. THE SAMPLE GENERATED AN INITIAL RESULT OF 79.2 NG/ML AND REPEAT 2.51 NG/ML. THE CUSTOMER INDICATED THE PATIENT'S PREVIOUS RESULT WAS 2.4 AND 2.6 NG/ML. NO SPECIFIC PATIENT INFORMATION WAS AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9935530 ↗
• MalfunctionAug 21, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT AFP RESULT FOR 1 SAMPLE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2019 SID (B)(6) INITIAL RESULT = 157 NG/ML, REPEATS = 8.7 NG/ML, 9.2 NG/ML. PATIENT'S HISTORY = 10 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8916240 ↗
• MalfunctionJun 9, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED RESULT FOR ARCHITECT AFP. THE CUSTOMER PROVIDED SID (B)(6) INITIAL RESULT 124.12 NG/ML, REPEATS 3.98, 4.23. THERE WAS NO IMPACT ON PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8681291 ↗
• MalfunctionMay 10, 2019High Test Results; High Test Results

  ADDTIONAL INFORMATION FROM THE CUSTOMER STATED THAT ON ADMISSION THE PATIENT UNDERWENT AN MRI EXAMINATION AND THE PATIENT WAS DISCHARGED WITHOUT ANY PARTICULAR MEDICATION OR TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8599438 ↗
• MalfunctionMar 20, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED AFP RESULT FOR ONE PATIENT WHILE USING THE ARCHITECT AFP ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA: INITIAL: 983.93 NG/ML, RETEST 1.75 NG/ML, RETEST ON SECOND ANALYZER: 1.8 NG/ML. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8436308 ↗
• MalfunctionMar 3, 2019High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT AFP RESULT OF 594.2 UG/L WAS GENERATED FOR A MALE PATIENT (SAMPLE ID (B)(6). THE SAMPLE WAS RETESTED BECAUSE A DELTA CHECK WAS GENERATED AS THE PATIENT'S PREVIOUS RESULT WAS 3.3 UG/L. THE SAMPLE RETESTED AT 3.4 UG/L TWICE. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384882 ↗
• MalfunctionFeb 18, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED DISCREPANT ALPHA 1 FETOPROTEIN (AFP) RESULTS ON THE ARCHITECT ANALYZER. THE FOLLOWING DATA PROVIDED: INITIAL 14, REPEATS 10, 20 FOR A PATIENT BETWEEN THE AGES OF 1 AND 3 YEARS OLD. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8348266 ↗
• MalfunctionSep 24, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED AFP RESULT FOR ONE PATIENT WHILE USING THE ARCHITECT AFP ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR A (B)(6) FEMALE PATIENT: INITIAL: 725.3 NG/ML, THE AVERAGE OF THE FIRST 2 RETEST RESULTS PROVIDED WAS 1.7 NG/ML A THIRD RETEST GENERATED A RESULT OF 1.7 NG/ML THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7902148 ↗
• MalfunctionAug 6, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALPHA-FETOPROTEIN RESULTS WHILE USING ARCHITECT AFP REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) INITIAL 9.96 NG/ML, REPEAT 10.15 NG/ML. PREVIOUSLY, THE PATIENT RESULTS RANGED FROM 200 TO 500 NG/ML.. NO CHANGE TO SURGERY OR MEDICATION WAS REPORTED DUE TO THE ELEVATED VALUES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7754528 ↗
• MalfunctionAug 6, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALPHA-FETOPROTEIN RESULTS WHILE USING ARCHITECT AFP REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) INITIAL 9.96 NG/ML, REPEAT 10.15 NG/ML. PREVIOUSLY, THE PATIENT RESULTS RANGED FROM 200 TO 500 NG/ML. NO CHANGE TO SURGERY OR MEDICATION WAS REPORTED DUE TO THE ELEVATED VALUES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7754525 ↗
• MalfunctionSep 11, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALPHA-FETOPROTEIN (AFP) RESULTS WHILE USING THE ARCHITECT AFP REAGENTS. THE FOLLOWING DATA WAS PROVIDED. INITIAL 63.1 NG/ML, REPEAT 42.9 NG/ML. A NEW SPECIMEN WAS OBTAINED AND THE RESULT WAS LOWER, 2.2 NG/ML. RESULT FOR THIS SPECIMEN IN ANOTHER LABORATORY WAS 1.9 NG/ML. THE PATIENT IS A CHILD THAT WAS DIAGNOSED WITH IMMATURE TERATOMA OF THE RETROPERITONEAL SPACE AND WAS TREATED IN 2015. THE PATIENT WAS BEING MONITORED AFTER TREATMENT OF GERMOGENIC TUMORS. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6856406 ↗
• MalfunctionJul 31, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED AFP RESULT FOR ONE PATIENT WHILE USING THE ARCHITECT AFP ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA (NG/ ML): (B)(6) 2017: SID (B)(6): INITIAL: 50.89, RETEST AFTER CENTRIFUGATION: 31.11. THE SPECIMEN FROM (B)(6) 2017 WAS RETESTED ON (B)(6) 2017: RETESTS: 6.28 AND 6.01 A SECOND SPECIMEN WAS TESTED ON (B)(6) 2017: INITIAL 4.11 NG/ML THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6755014 ↗