ARCHITECT 03P6824Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380740169855), received between Apr 19, 2021 and Sep 14, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “High Test Results” (22 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026High Test Results

  The customer observed falsely elevated Magnesium generated from ARCHITECT analyzer and provided the following data for a 74 year old male:Sample ID: (b)(6) initial results was 2.48 mmol/L and repeat result on an Alinity analyzer was 0.83 mmol/L. There was no reported impact to patient management.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756353 ↗
• MalfunctionNov 4, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT. THE FOLLOWING RESULTS WERE PROVIDED: SID: (B)(6). GENDER: MALE AGE: 83 INITIAL RESULT 6.31 MG/DL, REPEATED 2.06 / 2.03 / 2.22 MG/DL. (CUSTOMER REF RANGE REF RANGE 1.8 -2.4 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464435 ↗
• MalfunctionSep 5, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON AN ARCHITECT C4000 ANALYZER FOR ONE PATIENT. SID (B)(6) INITIAL RESULT = 0.77 MMOL/L, REPEAT RESULTS = 0.53 MMOL/L. THE PREVIOUS RESULT FROM THE DAY PRIOR WAS 0.51 MMOL/L. THE CUSTOMER¿S NORMAL REFERENCE RANGE IS 0.7-1.1 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979542 ↗
• MalfunctionAug 18, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 1.5 ¿ 2.2 MG/DL): (B)(6) 2025, SID (B)(6) (NEWBORN), INITIAL MAGNESIUM RESULT= 5.95 MG/DL; 04AUG2025, REPEAT RESULT= 2.10 MG/DL. (B)(6) 2025, SID (B)(6), INITIAL MAGNESIUM RESULT= 8.54 MG/DL; REPEAT RESULT= 1.70 MG/DL . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828004 ↗
• MalfunctionMay 14, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR A MALE PATIENT. RESULTS WERE NOT REPORTED TO THE MEDICAL PROVIDER. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 1.8-2.6 MG/DL): INITIAL RESULT =7.1 MG/DL, REPEAT RESULTS = 1.8, 5.93, 1.73 AND 1.76 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019764 ↗
• MalfunctionNov 5, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM FLIER ON AN ARCHITECT C4000 PROCESSING MODULE FOR A PATIENT. RESULTS WERE NOT REPORTED TO THE MEDICAL PROVIDER. SID NUMBER OR REFERENCE RANGE WAS NOT AVAILABLE. THE FOLLOWING PATIENT DATA WAS PROVIDED INITIAL MAGNESIUM RESULT = 2.88 MMOL/L, REPEAT FROM ANOTHER ANALYZER= 0.9 MMOL/L, REPEAT ON THIS INSTRUMENT: 0.88, 0.88 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610316 ↗
• MalfunctionMay 21, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT FOR TWO PATIENTS. THE FOLLOWING DATA WAS PROVIDED (NORMAL REFERENCE RANGE 1.6-2.6 MG/DL): SID (B)(6) (39-YEAR-OLD FEMALE) (B)(6) 2024 INITIAL RESULT 7.69 MG/DL, REPEATED SAME SAMPLE 1.64 MG/DL, REPEATED SAME SAMPLE AFTER RE-RUNNING QC AND THE RESULT WAS 1.67 MG/DL. SID (B)(6) (77-YEAR-OLD FEMALE) (B)(6) 2024 INITIAL RESULT >9.5 MG/DL, REPEATED SAME SAMPLE 1.73 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359276 ↗
• MalfunctionDec 8, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT FOR ONE PATIENT ON AN ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 1.6-2.6 MG/DL): SAMPLE ID (B)(6)INITIAL RESULT WAS 6.44, REPEAT WAS 2.17, REPEAT, ON ANOTHER ANALYZER, WAS 3.5 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293087 ↗
• MalfunctionAug 30, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR TWO SAMPLES THAT WERE NOT RELEASED OUT OF THE LAB. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) ORIGINAL RESULT = 3.6671 MMOL/L, REPEAT RESULT = 0.9396 MMOL/L (B)(6) ORIGINAL RESULT = >3.9 MMOL/L, REPEAT RESULT = 0.9196 MMOL/L REFERENCE (NORMAL) RANGES: 0.66 TO 1.07 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650631 ↗
• MalfunctionJul 28, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 1.6 TO 2.6 MG/DL): 04JUL2023 (B)(6) INITIAL RESULT = 6.5 MG/DL, REPEAT = 1.93 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17418948 ↗
• MalfunctionJun 2, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0.7-1.1 MMOL/L): (B)(6) 2023 SAMPLE ID 681167149 INITIAL = 3.543 MMOL/L, REPEAT = 1.504 MMOL/L, 0.808 MMOL/L, 0.815 MMOL/L, 77% NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051016 ↗
• MalfunctionMay 22, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE SAMPLE. RESULTS PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE: 0.7 - 2.0 MG/DL). 24APR2023 INITIAL RESULT = > 9.5 MG/DL, REPEAT RESULT = 8.8 MG/DL, SAMPLE REPEATED A THIRD TIME = 2.0 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975024 ↗
• MalfunctionMay 10, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE SAMPLE. (CUSTOMER¿S PROVIDED MAGNESIUM NORMAL RANGE: 1.6 - 2.6 MG/DL). THE EXAMPLE RESULT WAS PROVIDED: ORIGINAL RESULT 5.59 MG/DL, REPEAT RESULT ON ANOTHER ARCHITECT = 1.22 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901784 ↗
• MalfunctionApr 14, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE SAMPLE. RESULTS PROVIDED: (CUSTOMER PROVIDED NORMAL RANGE = 1.6-2.6 MG/DL). SID (B)(6) INITIAL RESULT = 9.0 MG/DL, REPEAT RESULT = 1.7 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16741810 ↗
• MalfunctionApr 4, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM (MG) RESULTS GENERATED ON THE ARCHITECT C4000 FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 1.8 - 2.6 MG/DL): SAMPLE ID 206627952801 INITIAL RESULT = 7.37 MG/DL, REPEAT = 2.08 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672698 ↗
• MalfunctionMar 31, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER ON A PATIENT. RESULTS PROVIDED: 3.8 / 1.3 MG/DL (REFERENCE RANGE: 1.6 - 2.6 MD/DL). NO IMPACT TO PATIENT MANAGEMENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16655420 ↗
• MalfunctionOct 18, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED MAGNESIUM RESULT FOR A PATIENT WHILE RUNNING ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING RESULTS WERE PROVIDED (NORMAL RANGE: 1.6-2.6 MG/DL): ON (B)(6) 2022, SID (B)(6): INITIAL RESULT: 1.08 MG/DL. REPEAT TESTING: 1.79, 1.14, 1.13 MG/DL. THE CUSTOMER WAS QUESTIONING THE ELEVATED MAGNESIUM RESULT OF 1.79 MG/DL. THE CUSTOMER THEN WENT AND TESTED THE SAMPLE ON ANOTHER ARCHITECT FOR VERIFICATION: ON (B)(6) 2022, SID (B)(6): RESULTS WERE: 1.138, 1.110, 1.152, 1.119, 1.138, AND 1.129 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626417 ↗
• MalfunctionJul 8, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT MAGNESIUM RESULT OF 8.49 MG/DL RETESTED AT 1.45, 1.48, 1.51 AND 1.47 MG/DL. THE CUSTOMER NORMAL RANGE IS 1.6 - 2.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959623 ↗
• MalfunctionMay 20, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT 1.65 MMOL/L, REPEATED 0.37 MMOL/L. REPEATED ON ANOTHER INSTRUMENT 0.36 AND 0.37 MMOL/L. THE CUSTOMER TRANSMITTED THE CORRECT RESULT (0.37 MMOL/L) TO THE MEDICAL TEAM AS THERE WAS PRECISION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463819 ↗
• MalfunctionAug 19, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY INCREASED MAGNESIUM (MG) RESULT GENERATED ON THE ARCHITECT C16000 ANALYZER ON A PATIENT. RESULTS PROVIDED: (B)(6) 2021 SID (B)(6) = 3.57 / 0.71 MMOL/L. NORMAL RANGE: 0.66-1.07 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342291 ↗
• MalfunctionMay 10, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS WERE GENERATED FOR A SAMPLE ON THE ARCHITECT C16000 ANALYZER. THE CUSTOMER STATED SAMPLE NO. (B)(6) GENERATED AN INITIAL RESULT OF 3.38 MMOL/L, WITH REPEAT RESULTS OF 0.60 MMOL/L AND 0.60 MMOL/L. THE CUSTOMER THEN REPORTED THE SAMPLE GENERATED A RESULT OF 3.68 MMOL/L AND THEN REPEATED WITHIN NORMAL RANGE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797247 ↗
• MalfunctionApr 19, 2021High Test Results; High Test Results

  THE ACCOUNT OBSERVED A FALSE ELEVATED ARCHITECT MAGNESIUM OF 3.7 MMOL/L ON A (B)(6) YEAR OLD MALE PATIENT WHO REPEATED 0.69 AND 0.71 MMOL/L WHEN PROCESSING ON THE ARCHITECT C16000. THE ACCOUNT USES AN ADULT MAGNESIUM REFERENCE RANGE OF 0.66 TO 1.07 MMOL/L. NO RACE/ETHNICITY PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11689468 ↗