ARCHITECT 03P6822Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00380740161620), received between Jun 26, 2019 and Aug 26, 2024 — classified as 43 malfunctions.

The most frequently reported specific device problem is “High Test Results” (41 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON AN ARCHITECT C4000 ANALYZER FOR ONE PATIENT. THE INITIAL RESULT = 7.56 MG/DL, REPEAT RESULT = 1.83 MG/DL (REFERENCE RANGE 1.6-2.6 MG/DL). THERE WAS NO IMPACT TO PATIENT MANAGEMENT. UPDATE: PATIENT SAMPLE ID: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063115 ↗
• MalfunctionJul 6, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE SAMPLE THAT WAS NOT RELEASED OUT OF THE LAB. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6)ORIGINAL RESULT = 7.5 MG/DL, RERUN RESULT ON ANOTHER ARCHITECT = 1.9 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265847 ↗
• MalfunctionFeb 6, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE ELEVATED MAGNESIUM RESULT GENERATED ON ARCHITECT C4000 ANALYZER FOR ONE SAMPLE. RESULTS PROVIDED: CUSTOMER NORMAL RANGE 1.6 ¿ 2.6 MG/DL. (B)(6) 2023, SID (B)(6), INITIAL RESULT 7.8 MG/DL, REPEAT RESULT ON SAME ANALYZER 1.8 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16302835 ↗
• MalfunctionSep 16, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER ON A PATIENT. RESULTS PROVIDED: (B)(6) 2022, SID (B)(6) = 4.3 / 1.3 MG/DL, ANOTHER ARCHITECT = 1.4 MG/DL. (NORMAL RANGE - 1.6 - 2.6 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436908 ↗
• MalfunctionAug 30, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT MAGNESIUM RESULT OF 6.79 MG/DL WAS GENERATED FOR A PATIENT SAMPLE (B)(6) THAT RETESTED AT 2.0 AND 2.1 MG/DL. REFERENCE RANGE: 1.9 - 2.8 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324519 ↗
• MalfunctionMar 17, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED A (B)(6) MAGNESIUM RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER ON A PATIENT. RESULTS PROVIDED: (B)(6) 2022 (B)(6). NORMAL RANGE: 1.6-2.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801480 ↗
• MalfunctionMar 2, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS WHICH QUESTIONED BY PHYSICIAN ON ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID (B)(6) INITIAL=8.21 MG/DL /REPEATED=2.24 MG/DL. LABORATORY REFERENCE RANGE FOR MAGNESIUM= (B)(4). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13654646 ↗
• MalfunctionFeb 7, 2022High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT MAGNESIUM OF (B)(6) MG/DL ON A SAMPLE ((B)(6) YEAR OLD, FEMALE, CAUCASIAN PATIENT) THAT REPEATED (B)(6) MG/DL. THE ACCOUNT USES A NORMAL MAGNESIUM RANGE OF 1.6 TO 2.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477124 ↗
• MalfunctionDec 13, 2021High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED MAGNESIUM RESULT WHILE USING THE ARCHITECT C4000 ANALYZER. ON (B)(6) 2021 SAMPLE ID (B)(6) GENERATED A RESULT OF 8.0 MG/DL. THE PHYSICIAN QUESTIONED THE RESULT AND A NEW SAMPLE ((B)(6) GENERATED 0.9 MG/DL. THE ORIGINAL SAMPLE WAS RETESTED AND GENERATED 0.8 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12985141 ↗
• MalfunctionNov 4, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON AN ARCHITECT C4000 ANALYZER FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RESULT = 2.59 MMOL/L; REPEAT RESULT = 0.81 MMOL/L. SID (B)(6) INITIAL RESULT = 3.87 MMOL/L; REPEAT RESULT = 0.94 MMOL/L. PATIENT 3 (SID NOT PROVIDED) INITIAL RESULT = 3.5 MMOL/L; REPEAT RESULT - 0.7 MMOL/L. PATIENT 4 (SID NOT PROVIDED) INITIAL RESULT = 2.6 MMOL/L; REPEAT RESULT = 1.0 MMOL/L. SID (B)(6) INITIAL RESULT = 2.77 MMOL/L; REPEAT RESULT = 0.987 MMOL/L. SID (B)(6) INITIAL RESULT = 3.71 MMOL/L, REPEAT RESULT = 0.83 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752256 ↗
• MalfunctionAug 27, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE PATIENTS. THE FEW RESULTS EXAMPLES PROVIDED WERE: ON (B)(6) 2021 PATIENT 1: INITIAL=3.9 MMOL/L /REPEATED=0.71 MMOL/L. PATIENT 2: INITIAL=3.2 MMOL/L /REPEATED=0.67 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378047 ↗
• MalfunctionJul 12, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT FOR ONE PATIENT. SID (B)(4) GENERATED AN INITIAL MAGNESIUM RESULT OF 2.47 MMOL/L, REPEATED 1.0 MMOL/L AND 1.01 MMOL/L. THE DISCREPANT RESULT WAS NOT REPORTED OUT OF THE LAB. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150094 ↗
• MalfunctionJun 30, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 INSTRUMENT FOR ONE PATIENT. SID (B)(6) GENERATED AN INITIAL RESULT OF 6.83 MG/DL, REPEATED 0.99 MG/DL, REPEATED AGAIN ON ANOTHER INSTRUMENT AND THE RESULT WAS 0.94 MG/DL (REFERENCE RANGE IS 2.1 TO 2.8 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094626 ↗
• MalfunctionJun 24, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT FOR TWO PATIENTS ON AN ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 1.60-2.60 MG/DL): SAMPLE ID (B)(4) INITIAL RESULT WAS 8.14, REPEAT WAS 2.11 MG/DL SAMPLE ID (B)(4) INITIAL RESULT WAS 3.2, REPEAT WAS 1.3, REPEATED ON ANOTHER ANALYZER WAS 1.2 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058248 ↗
• MalfunctionJun 11, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT FOR ONE PATIENT ON AN ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 1.5-2.3 MG/DL): SAMPLE ID (B)(6) INITIAL RESULT WAS 6.2, REPEATS WERE 1.8 AND 1.8 MG/DL, WHEN REPEATING ON AN ARCHITECT C4000 THE RESULT WAS 1.7 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987237 ↗
• MalfunctionMar 4, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 ANALYZER ON TWO PATIENTS. RESULTS PROVIDED: (B)(6) 2021 SID (B)(6) = 8.5 / 2.1 MG/DL, ANOTHER ARCHITECT = 2.1 MG/DL, (B)(6) 2021 SID (B)(6) = 6.4 / 2.0 MG/DL. NORMAL RANGE: 1.6 -2.6 MG/D. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11416686 ↗
• MalfunctionDec 21, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS FOR SEVERAL PATIENTS 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 3.6, REPEAT WAS 1.3 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11050608 ↗
• MalfunctionDec 11, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT MAGNESIUM RESULT FOR ONE PATIENT. THE CUSTOMER PROVIDED: SID: (B)(6); INITIAL = 0.85 MMOL/L, REPEATS 0.88 MMOL/L, 2.51 MMOL/L (NORMAL RANGE: 0.62 MMOL/L TO 1.07 MMOL/L). OTHER TEST RESULTS, THAT WERE NOT MAGNESIUM, PROVIDED BY THE CUSTOMER, WERE ALSO REVIEWED, AND NONE MET REPORTING CRITERIA. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10991722 ↗
• MalfunctionNov 18, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED MAGNESIUM (MG) RESULTS FOR 2 PATIENTS WHILE RUNNING ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 1.6 TO 2.6 MG/DL): ON (B)(6) 2020 SAMPLE 1: MG = INITIAL = 8.6 MG/DL, REPEAT = 2.1 MG/DL. ON (B)(6) 2020 SAMPLE 2: MG = INITIAL = 7.3 MG/DL, REPEAT = 2.5 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10865344 ↗
• MalfunctionNov 11, 2020High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED ARCHITECT MAGNESIUM RESULT WHILE USING THE ARCHITECT C4000 ANALYZER. SAMPLE ID: (B)(6), GENERATED AN INITIAL RESULT OF 6.6 MG/DL, AND REPEAT 1.96 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10825505 ↗
• MalfunctionNov 3, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS FOR 3 PATIENTS WHILE RUNNING ON THE ARCHITECT C4000 PROCESSING MODULE. THE CUSTOMER WAS ONLY ABLE TO PROVIDE DISCREPANT RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER'S REFERENCE RANGE: 1.3 TO 2.1 MG/DL): SID: (B)(6) = INITIAL RESULT = 6.25 MG/DL, REPEAT = 1.43, 1.4 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10782794 ↗
• MalfunctionSep 22, 2020High 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'S NORMAL RANGE: 1.6 TO 2.6 MG/DL): SID (B)(6) INITIAL RESULT = 6.5 MG/DL, REPEAT AFTER THE PHYSICIAN QUESTIONED THE RESULT = 1.6 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10571115 ↗
• MalfunctionJul 27, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED MAGNESIUM RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 SID (B)(6) INITIAL = 8.09MG/DL (1.6 - 2.6MG/DL); 2.02MG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10327027 ↗
• MalfunctionJul 21, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT MAGNESIUM RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2020 SID (B)(6) = >9.5 MG/DL, REPEATED 9.7, 1.82 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10304556 ↗
• MalfunctionJul 20, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED 2 FALSELY ELEVATED ARCHITECT MAGNESIUM RESULTS. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. SID (B)(6): INITIAL RESULT OF >9.5 MG/DL RETESTED AT 1.94 AND 1.95 MG/DL. SID (B)(6): INITIAL RESULT OF 5.38 MG/DL RETESTED AT 9.7 MG/DL (1:5 DILUTION) AND 1.82 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10298887 ↗