ARCHITECT 3L82-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380740161583), received between Jul 28, 2020 and Nov 11, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED GLUCOSE RESULTS GENERATED FROM THE ARCHITECT ANALYZER AND PROVIDED THE FOLLOWING DATA: THE INITIAL TEST RESULT WAS 11.89 MMOL/L (214.2102 MG/DL), WHICH WAS REPORTED TO THE CLINICAL PHYSICIAN. THE RETEST RESULTS WERE 6.30 AND 6.07 MMOL/L (109.3571 MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525791 ↗
• MalfunctionFeb 19, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED GLUCOSE RESULT ON THE ARCHITECT C4000, SERIAL NUMBER (B)(6), FOR ONE PATIENT. THE SAMPLE WAS REPEATED AND THE RESULTS WERE LOWER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT PROCESSED ON (B)(6) 2025 = 429.9 MG/DL REPEAT RESULTS = 192 AND 193 MG/DL. REFERENCE RANGE = ADULT: 70 TO 105 MG/DL (FASTING) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414286 ↗
• MalfunctionDec 28, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT GLUCOSE RESULTS GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT = 386 MG/DL, REPEAT RESULT 2 HOURS LATER = 149 MG/DL, AND 147 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409336 ↗
• MalfunctionFeb 28, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED GLUCOSE RESULT FOR A DIABETIC MALE PATIENT GENERATED FROM AN ARCHITECT C8000 ANALYZER AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2023, SAMPLE ID (B)(6): INITIAL RESULT WAS 16 MG/DL, REPEAT RESULT WAS 16 MG/DL. THE PATIENT WAS TESTED IN ANOTHER LABORATORY THE SAME DAY AND THE GLUCOSE RESULT WAS 180 MG/DL (METHOD UNKNOWN). IT WAS REPORTED THAT ALL GLUCOSE TESTING WAS NOT A FASTING GLUCOSE TEST. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454982 ↗
• MalfunctionFeb 9, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED DISCREPANT GLUCOSE RESULTS GENERATED FROM AN ARCHITECT C4000. IT WAS REPORTED THAT PATIENTS WITH A LOW GLUCOSE RESULT GENERATED FROM THE ARCHITECT ANALYZER WERE ALSO TESTED WITH A POINT OF CARE (POC) GLUCOSE MACHINE, WHICH GENERATED RESULTS THAT REPORTEDLY AGREED WITH THE PATIENT HISTORY. THE CUSTOMER PROVIDED THE FOLLOWING DATA (UNIT OF MEASURE ¿ MG/DL): NO SAMPLE ID, DATE : (B)(6) 2023, ARCHITECT RESULT = 27, POC RESULT = 128, REPEAT POC RESULT = 128. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330763 ↗
• MalfunctionJul 20, 2022Low Readings; Low Readings

  THE CUSTOMER OBSERVED FALSELY DECREASED GLUCOSE RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER FOR ONE PATIENT SAMPLE. THE CUSTOMER REPEATED THE SAMPLE ON ANOTHER ANALYZER AND THE RESULT WAS HIGHER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) INITIAL RESULT = < 10 MG/DL (SODIUM FLUORIDE). (B)(6) REPEAT RESULT ON ANOTHER ANALYZER (AC04028) = 130 MG/DL (PLASMA SUPERNATANT). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064097 ↗
• MalfunctionOct 11, 2021High Test Results; High Test Results

  THE CUSTOMER OBTAINED FALSELY ELEVATED GLUCOSE RESULTS WHILE USING THE ARCHITECT C4000 ANALYZER. ON (B)(6) 2021, SAMPLE ID (B)(6) GENERATED A RESULT OF 382, AND ON THE ROCHE AT AN ALTERNATE HOSPITAL, 140. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12609098 ↗
• MalfunctionJul 28, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED GLUCOSE RESULT ON THE ARCHITECT C8000 PROCESSING MODULE FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2020 SID (B)(6) = INITIAL RESULT = 589 MG/DL, REPEAT RESULT = 593 MG/DL (SAME ANALYZER), REPEAT RESULT = 593 MG/DL (ANOTHER ARCHITECT ANALYZER), ON (B)(6) 2020 REPEAT RESULT = 535 MG/DL (RADIOMETER-BLOOD GAS ANALYZER). ON (B)(6) 2020 NEW SAMPLE WAS COLLECTED AND GENERATED A RESULT OF 82 MG/DL AND REPEAT RESULT OF 84 (BLOOD GAS ANALYZER). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10335247 ↗