ARCHITECT 1L75-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380740001315), received between Nov 14, 2016 and Feb 5, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT WAS 115.0, REPEAT RESULT WAS 183.1 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21316339 ↗
• MalfunctionJan 3, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULTS FOR A 24-YEAR-OLD PATIENT UNDERGOING TREATMENT FOR APLASTIC ANEMIA WITH CYCLOSPORINE. THE PATIENT TOOK CYCLOSPORINE (TIANKE) 100G ONCE EVERY 12 HOURS. THE SPECIFIC TIME OF BLOOD DRAW WAS NOT ABLE TO BE PROVIDED BY THE PHYSICIAN. THE FOLLOWING CYCLOSPORINE RESULTS WERE PROVIDED: TROUGH RESULT = 87.9 NG/ML PEAK RESULT = 743.30 NG/ML THE PHYSICIAN FELT THAT THE PEAK RESULT WAS TOO HIGH IN COMPARISON TO THE PATIENT¿S PREVIOUS PEAK VALUES IN PAST CLINICAL HISTORY. THE QC WAS WITHIN RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21071790 ↗
• MalfunctionOct 25, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT CYCLOSPORINE RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING RESULTS FROM (B)(6) 2024 WERE PROVIDED: INITIAL RESULT = 72.8 NG/ML, REPEAT RESULT = 154.9 NG/ML INITIAL RESULT = 71.5 NG/ML, REPEAT RESULT = 181.3 NG/ML INITIAL RESULT = 53.2 NG/ML, REPEAT RESULT = 153.7 NG/ML INITIAL RESULT = 77.4 NG/ML, REPEAT RESULT = 211.9 NG/ML INITIAL RESULT = 48.3 NG/ML, REPEAT RESULT = 162.9 NG/ML INITIAL RESULT = 60.2 NG/ML, REPEAT RESULT = 244.9 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532819 ↗
• MalfunctionJan 8, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CYCLOSPORINE, WHICH REPORTEDLY OCCURRED ON APPROXIMATELY 3 PATIENTS. THE CUSTOMER STATED THAT THE RESULTS WERE QUESTIONED, AND SAMPLES WERE PROCESSED AGAIN WITH A NEW PRETREATMENT SET UP, AND RESULT WAS LOWER. THE CUSTOMER PROVIDED THE FOLLOW DATA FOR 1 PATIENT: CUSTOMER REFERENCE RANGE IS: 100.0 NG/DL TO 400 NG/ML. SAMPLE ID (B)(6): ON (B)(6), INITIAL RESULT WAS 167.5, AND REPEAT RESULT WAS <30 AND <30. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: ADDITIONAL INFORMATION RECEIVED: THE CUSTOMER REPORTED THAT THE ISSUE WAS DUE TO A HUMAN ERROR WITH THE PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18470051 ↗
• MalfunctionFeb 16, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED ARCHITECT CYCLOSPORINE RESULT FOR ONE PATIENT A 17 YEAR-OLD FEMALE WITH APLASTIC ANEMIA. THE RESULTS WERE LOWER THAN PREVIOUS RESULTS. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 139.4 NG/ML RETEST RESULT = 117.0 NG/ML HISTORICAL TEST RESULTS = FROM (B)(6) 2022 = 217.2 NG/ML FROM (B)(6) 2022 = 187.0 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16392964 ↗
• MalfunctionAug 4, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT CYCLOSPORINE RESULT WHICH QUESTIONED BY PHYSICIAN ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL=63 NG/ML /REPEATED=69 NG/ML /REDRAWN AND REPEATED ON SAME PATIENT=170 NG/ML AND 180 NG/ML /INITIAL SPECIMEN REPEATED=69 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15165222 ↗
• MalfunctionJul 25, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ARCHITECT CYCLOSPORINE RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT, AFTER RECEIVING MEDICATION ON 11JUL, WAS 872.5, REPEAT, ON 13JUL, WAS 4.3 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099869 ↗
• MalfunctionFeb 23, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT CYCLOSPORINE RESULTS ON ONE (B)(6) MALE PATIENT SAMPLES. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID (B)(6) =198.4 NG/ML. ON (B)(6) 2022 SID (B)(6) = 235.8 NG/ML. ON (B)(6) 2022 SID (B)(6) =121.0 NG/ML. THE PHYSICIAN CONCERNED OF CYCLOSPORINE RESULT ON (B)(6) 2022 LOWER COMPARE TO PREVIOUS RESULTS WITHOUT CHANGING ANY MEDICATION. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585894 ↗
• MalfunctionAug 20, 2021Low Test Results; Low Test Results

  THE CUSTOMER IDENTIFIED FALSELY DEPRESSED ARCHITECT CYCLOSPORINE RESULTS FOR ONE PATIENT THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT HISTORY - DOSAGE WAS 4 TABLETS, WITH RESULTS 90-110NG/ML FOR A DURATION OF 10 YEARS. EARLY (B)(6) 2021, DOSAGE REDUCED TO 3 TABLETS, RESULTS WERE APPROXIMATELY 50 NG/ML. THE CUSTOMER EXPECTED THE RESULTS TO BE APPROXIMATELY 67-82 NG/ML. LATE (B)(6) 2021 DOSAGE INCREASED TO 4 TABLETS; RESULT APPROXIMATELY 50 NG/ML. THE CUSTOMER EXPECTED THE RESULTS TO BE 90-110 NG/ML. THE PATIENT IS PERFORMING NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348564 ↗
• MalfunctionAug 27, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULTS FOR A (B)(6) YEAR OLD MALE PATIENT WITH NEPHROSIS. THE PATIENT IS TAKING NEORAL 25MG TWICE A DAY SINCE (B)(6) 2020. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2020 RESULT BEFORE ADMINISTERING THE MEDICATION = 96 NG/ML, POST ONE HOUR >1500 NG/ML, POST 2 HOURS = 1134 NG/ML, POST 4 HOURS = 400 NG/ML. ON (B)(6) 2020 RESULT BEFORE ADMINISTERING THE MEDICATION = 105 NG/ML, POST ONE HOUR = 137 NG/ML, POST 2 HOURS = 357 NG/ML, POST 4 HOURS = 735 NG/ML. THE CUSTOMER BELIEVES THERE SHOULD BE A PEAK WITH THE ONE HOUR VALUE AND WILL GRADUALLY DECREASE AFTER. THE PATIENT RECEIVED THE MEDICATION WHILE EATING A MEAL DURING THE LAST ADMINISTRATION. THE DOCTOR IS INQUIRING IF THERE IS ANY IMPACT ON THE RESULTS IF THE ADMINISTERING TIME IS DURING A MEAL AND IF THERE ARE ANY SPECIFIC MEALS THAT GIVE AN IMPACT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10460145 ↗
• MalfunctionDec 19, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULTS FOR 2 PEDIATRIC PATIENTS. THE PATIENTS ARE A (B)(6) YEAR OLD WITH ARCHITECT CYCLOSPORINE MEASUREMENTS EVERY 2-3 WEEKS. THE RESULTS USUALLY ARE AROUND 100 NG/ML BUT HAVE BEEN MEASURING HIGH AROUND 130 NG/ML, 150 NG/ML, AND 170NG/ML SINCE (B)(6) 2019. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9498088 ↗
• MalfunctionOct 23, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CYCLOSPORINE RESULTS. THE FOLLOWING INITIAL AND REPEAT RESULTS WERE PROVIDED: SAMPLE ID (B)(6): 171.2, 29.1 AND 39.4 NG/DL , SAMPLE ID (B)(6): 306.7, 77.2 AND 79.3 NG/DL . NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9226536 ↗
• MalfunctionApr 2, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT CYCLOSPORINE RESULT FOR A 69 YEAR OLD MALE WITH MYASTHENIA GRAVIS. THE SAMPLE GENERATED A RESULT OF APPROXIMATELY 400 AND RETEST GENERATED 200. THE CUSTOMER INDICATED THE PATIENT'S RESULTS PRIOR TO LAST MONTH WERE LESS THAN 30. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8474436 ↗
• MalfunctionMar 28, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSE DECREASED CYCLOSPORINE RESULTS WHEN PROCESSING ON THE ARCHITECT I2000SR. THE FOLLOWING DATA WAS PROVIDED: THE FIRST PATIENT RESULT HAD AN INITIAL RESULT OF 101.10 AND A RETEST RESULT OF 62.00. ANOTHER PATIENT RESULT (SID (B)(6)) HAD AN INITIAL RESULT OF 70.30 AND RETEST RESULT OF 39.90. UNITS OF MEASURE WERE NOT PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8462709 ↗
• MalfunctionSep 14, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CYCLOSPORINE RESULTS ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED (NG/ML): (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7877084 ↗
• MalfunctionAug 29, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED RESULTS WHILE USING ARCHITECT CYCLOSPORINE REAGENTS. THE CUSTOMER STATED THE ARCHITECT METHOD VALUES WERE LOWER IN THEIR LAB THAN IN ANOTHER SUPPORT LAB USING THE SAME METHOD, HOWEVER SPECIFIC RESULTS FOR THE SPECIMEN WERE NOT PROVIDED. THE FOLLOWING DATA WAS PROVIDED FOR A SPECIMEN WITH A KNOWN VALUE (106 NG/ML). INITIAL 112.3 NG/ML, REPEAT 63.5, 94.4 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7827876 ↗
• MalfunctionNov 14, 2016Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CYCLOSPORINE RESULTS WHILE USING THE ARCHITECT CYCLOSPRORINE ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA: PATIENT 1: INITIAL 18.6, RETESTS 84, 66, 243, 194, PATIENT 2: INITIAL 164.4, RETESTS 41, 45, 68, 21, 57, 29.2, PATIENT 3: INITIAL 107.4, RETESTS 217, 60, 343, 36, 70, 21.7, PATIENT 4: INITIAL 4.8, RETESTS 36, 185, 133, 27, 53, 94.8, PATIENT 5: INITIAL 6, RETESTS 99, 82, 25, 43, 230, 126.9, PATIENT 6: INITIAL 49.1, RETESTS 25, 122, 265, 122, 67, 29.6, PATIENT 7: INTIAL 4.5 RETESTS 14.5, 39, 308, PATIENT 8: INITIAL 68.2, RETESTS 101, 263, PATIENT 9: INTIIAL 25.9, RETESTS 85, 223, 323. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6098692 ↗