ARCHITECT 03P6834Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380740169862), received between Dec 28, 2022 and Jun 2, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) = 3.21 / 0.86 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121915 ↗
• MalfunctionMay 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 0.61-1.03 MMOL/L): INITIAL RESULT = 1.02 MMOL/L; REPEAT RESULT = 0.52 MMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047642 ↗
• MalfunctionNov 4, 2024High 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 RESULTS WERE PROVIDED: (CUSTOMER PROVIDED NORMAL RANGE FOR MG+ 1.6-2.6 MG/DL) (B)(6) 2024 INITIAL RESULT = 6.2 MG/DL, REPEAT RESULT ON ANOTHER INSTRUMENT = 1.8 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599226 ↗
• MalfunctionMay 22, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULT FOR ONE PATIENT ON AN ARCHITECT C16000. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 1.6-2.6 MG/DL): SAMPLE ID (B)(6) INITIAL RESULT WAS 8.2, REPEAT WAS 2.1 MG/DL. THE SAMPLE WAS REPEATED FIVE TIMES FOR A PRECISION STUDY AND THE RESULTS WERE ALL 2.1 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373172 ↗
• MalfunctionJul 21, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) INITIAL RESULT = 3.165 MMOL/L, REPEAT = 0.924 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17373628 ↗
• MalfunctionDec 28, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING EXAMPLE RESULTS WERE PROVIDED: ON (B)(6) 2022. INITIAL RESULT = 7.9MGDL, REPEAT RESULT ON ANOTHER ANALYZER= 1.3MG/DL. ON (B)(6) 2022. INITIAL RESULT = 6MG/DL, REPEAT RESULT ON ANOTHER ANALYZER= 2.1MG/DL REFERENCE (NORMAL) RANGE: 1.6 TO 2.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059207 ↗