ARCHITECT 3L80-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740161538), received between Sep 1, 2020 and Jul 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CARBON DIOXIDE RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID: (B)(6): INITIAL RESULT = 9.2 MMOL/L, REPEAT = 9.9 MMOL/L, VITROS RESULT = 18 MMOL/L, RADIOMETER RESULT = 23 MMOL/L. THE CUSTOMER INDICATED THE SAMPLE IS LIPEMIC. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553539 ↗
• MalfunctionFeb 27, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CO2 RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE SAMPLE. THE CUSTOMER REPEATED THE SAMPLE ON ANOTHER ARCHITECT AND THE RESULTS WERE LOWER. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 32 MMOL/L REPEAT RESULTS= 25 AND 26 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789983 ↗
• MalfunctionApr 28, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CARBON DIOXIDE RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE SAMPLE. RESULTS PROVIDED: INITIAL RESULT = 6.1 MMOL/L, REPEAT RESULT = 22.9 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831177 ↗
• MalfunctionSep 1, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT CO2 RESULTS FOR FOUR PATIENTS. THE CUSTOMER ALLEGES HAVING TO ISSUE ABOUT 500 CORRECTED CO2 REPORTS. HOWEVER, NO DATA IS AVAILABLE FOR THIS ALLEGATION. THE CUSTOMER DID PROVIDE INFORMATION FOR FOUR PATIENTS: PT#1 (B)(6): INITIAL = 16 MMOL/L, REPEAT = 22 MMOL/L; PT# 2: (B)(6)INITIAL = 20 MMOL/L, REPEAT = 27 MMOL/L; PT#3: (B)(6): INITIAL = 14 MMOL/L, REPEAT = 25 MMOL/L; PT#4: (B)(6): INITIAL = 16 MMOL/L, REPEAT = 25 MMOL/L (NORMAL RANGE: 20-29 MMOL/L). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10476215 ↗