ARCHITECT 03P6832Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380740161637), received between May 14, 2019 and Mar 5, 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.

• MalfunctionMar 5, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE 3 DAY OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED WITH A LOWER RESULT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL TEST 2.60 MMOL/L, RETEST 0.98 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519781 ↗
• MalfunctionJan 18, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE SAMPLE. (CUSTOMER PROVIDED REFERENCE RANGE WAS 0.7-1.1 MMOL/L) THE INITIAL TEST RESULT WAS 3.71MMOL/L, THE RETEST RESULTS WERE 0.84 MMOL/L,0.83 MMOL/L, 0.84 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533461 ↗
• MalfunctionJan 9, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID (B)(6) INITIAL=8.7 MG/DL /REPEATED ON SAME ANALYZER=2.07 MG/DL /REPEATED ON (B)(4) =2.08 MG/DL. CUSTOMER REFERENCE RANGE FOR MAGNESIUM=1.6 TO 2.6 MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16122286 ↗
• MalfunctionSep 2, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT MAGNESIUM RESULTS. RESULTS HAD TO BE CORRECTED FOR THREE PATIENTS. THE FOLLOWING DATA WAS PROVIDED. SID, ORIGINAL RESULT, REPEAT RESULT: (B)(6), 3.75 MG/DL, 1.17 MG/DL. (B)(6), 3.41 MG/DL, 1.90 MG/DL. (B)(6), 3.08 MG/DL, 2.24 MG/DL. PATIENT REFERENCE RANGE: 1.8 - 2.8 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349886 ↗
• MalfunctionJun 15, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULTS FOR ONE PATIENT ON AN ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 1.6-2.6 MG/DL): SAMPLE ID (B)(6) INITIAL RESULT WAS 3.91, REPEATS WERE 1.21 AND 1.26 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14705636 ↗
• MalfunctionNov 30, 2021High Test Results; High Test Results

  ADDITIONAL INFORMATION WAS PROVIDED THAT EXPIRED ARCHITECT MAGNESIUM REAGENT LOT 42219UN20 USED ON (B)(6) 2021 FOR TESTING PATIENT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894301 ↗
• MalfunctionSep 14, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT FOR A PATIENT WHILE RUNNING ON ARCHITECT C8000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE: 1.6 ¿ 2.6 MG/DL (16-26 MG/L)): SID (B)(6)= INITIAL RESULT = 8.61 MG/DL (86.1 MG/L) / REPEAT RESULT = 2.02 MG/DL (20.2 MG/L), 2.07 MG/DL (20.7 MG/L) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12469074 ↗
• MalfunctionAug 31, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED ARCHITECT MAGNESIUM IMPRECISION ON (B)(6) 2021. THE FOLLOWING DATA WAS PROVIDED. PATIENT ID (B)(6), INITIAL RESULT OF 4.13 MG/DL RETESTED AT 2.4 MG/DL. PATIENT ID (B)(6), INITIAL RESULT OF 4.66 MG/DL RETESTED AT 3.6 MG/DL. PATIENT ID (B)(6), INITIAL RESULT OF 4.15 MG/DL RETESTED AT 3.9 MG/DL. PATIENT ID (B)(6), INITIAL RESULT OF 6.90 MG/DL RETESTED AT 2.3 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393052 ↗
• MalfunctionMar 8, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM (MAG) RESULT ON C4000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021, SID (B)(6), INITIAL=7.3 MG/DL/REPEATED=2.1 MG/DL AND 2.2 MG/DL/PREVIOUS HISTORY=2.1 MG/DL. LABORATORY REFERENCE RANGE FOR MAGNESIUM=1.6 TO 2.6 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11438922 ↗
• MalfunctionJan 15, 2021High Test Results

  THE CUSTOMER GENERATED FALSELY ELEVATED MAGNESIUM RESULTS WHILE USING THE ARCHITECT C16000 PROCESSING MODULE. THE CUSTOMER'S NORMAL RANGE IS 1.6 - 2.6 MG/DL.THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6) NITIAL RESULT: 7.2 MG/DL, REPEAT 1.9 MG/DL ON A DIFFERENT ANALYZER. INITIAL RESULT: 7.2 MG/DL, REPEAT 1.9 MG/DL ON A DIFFERENT ANALYZER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11181645 ↗
• MalfunctionDec 16, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR TWO PATIENTS. THE RESULTS PROVIDED FROM THE SAMPLES COLLECTED ON (B)(6) 2020 WERE: PATIENT 1 INITIAL RESULT WAS 6.3 MG/DL, REPEATED 1.9 MG/DL; PATIENT 2 INITIAL RESULT WAS 6.3 MG/DL, REPEATED 1.9 MG/DL; (CUSTOMER REFERENCE RANGE 1.7 MG/DL TO 2.8 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11021520 ↗
• MalfunctionNov 24, 2020High Test Results; High Test Results

  THE CUSTOMER GENERATED FALSELY ELEVATED MAGNESIUM RESULTS FOR 1 PATIENT ON THE ARCHITECT C4000 PROCESSING MODULE. THE FOLLOWING INFORMATION WAS PROVIDED: SID (B)(6) RUN ON (B)(6) 2020, INITIAL 9.02 MG/DL, REPEAT 2.6 MG/DL. 2.6 MG/DL WAS REPORTED OUT OF THE LAB. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10896596 ↗
• MalfunctionNov 12, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT MAGNESIUM RESULT OF 3.61 MMOL/L FOR A PATIENT SAMPLE (SID (B)(6)) THAT RETESTED AT 0.73 AND 0.74 MMOL/L. THE ELEVATED RESULT WAS NOT REPORT OUT OF THE LAB. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10829916 ↗
• MalfunctionOct 23, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2020; (B)(6)= 7.4 / 1.78 MG/DL. NORMAL RANGE: 1.6-2.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10726763 ↗
• MalfunctionOct 19, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM (MAG)RESULTS ON ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: SID: (B)(6); INITIAL MAG RESULT=1.9 MG/DL/ REPEATED=6.3 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10697784 ↗
• MalfunctionJun 10, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS: INITIAL 11.66 MG/DL; REPEAT 1.8 MG/DL ON THE ARCHITECT C16000 SYSTEM. THE CUSTOMER'S REFERENCE RANGE IS 1.6 TO 2.6 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138775 ↗
• MalfunctionApr 8, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS: INITIAL 11.66 MG/DL; REPEAT 1.8 MG/DL ON THE ARCHITECT C16000 SYSTEM. THE CUSTOMER'S REFERENCE RANGE IS 1.6 TO 2.6 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9936441 ↗
• MalfunctionMar 31, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR 1 SAMPLE. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE: 0.65 TO 1.05 MMOL/L): 09MAR2020 SID P5091588 INITIAL RESULT = 2.63 MMOL/L, REPEAT = 0.79 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9904050 ↗
• MalfunctionDec 20, 2019High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT MAGNESIUM RESULT OF 7.56 MG/DL RETESTED AT 2.38 AND 2.31 MG/DL FOR PATIENT SAMPLE ID (B)(6). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9501418 ↗
• MalfunctionDec 3, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS FOR THREE PATIENT SAMPLES TESTED ON THE ARCHITECT C16000 SYSTEM. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. (B)(6) INITIAL RESULT 6.7 MEQ/L (QUESTIONED BY PHYSICIAN) REPEAT 2.1 MEQ/L. A CORRECTED REPORT WAS ISSUED. (B)(6) INITIAL RESULT >7.8 MEQ/L, REPEAT 4.35 AND 4.17 MEQ/L. (B)(6) INITIAL RESULT 6.9 MEQ/L, REPEAT 2.7 MEQ/L.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405375 ↗
• MalfunctionJun 28, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C16000. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 6.19 MG/DL, REPEAT = 2.42 MG/DL. MAGNESIUM PACKAGE INSERT NORMAL RANGE = 1.6 TO 2.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745841 ↗
• MalfunctionMay 14, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT MAGNESIUM RESULTS. THE SAMPLE GENERATED AN INITIAL RESULT OF 2.97 MMOL/L AND RETEST OF 0.86 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8609105 ↗