ARCHITECT 3L81-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380740161569), received between Jan 4, 2021 and Dec 23, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE ON A PATIENT. RESULTS PROVIDED: SID (B)(6) = 689 / 62.3 UMOL/L (REFERENCE RANGE: 57-111 UMOL/L) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879374 ↗
• MalfunctionJun 16, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS FOR A 5-YEAR-OLD KIDNEY TRANSPLANT PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6), INITIAL CREATININE RESULT WAS 9.04 MG/DL, REPEATED 0.52 AND 0.56 MG/DL (CREATININE NORMAL RANGE 0.57-1.11 MG/DL). SPECIMEN INTEGRITY: SAMPLE SEEMED VISCOUS. THE CUSTOMER STATED THE PATIENT WAS SENT TO ER DUE TO DISCREPANT CREATININE AND THE REDRAW IN THE ER WAS NORMAL. THERE WAS NO KNOWN TREATMENT GIVEN IN THE ER. REDRAW SID (B)(6), (B)(6) 2025 CREATININE RESULT 0.61 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213038 ↗
• InjuryApr 8, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CREATININE RESULTS FOR A 70-YEAR-OLD MALE ADMITTED TO THE HOSPITAL FOR TREATMENT OF RENAL INSUFFICIENCY. THE CLINICAL DIAGNOSIS WAS CHRONIC KIDNEY DISEASE STAGE III WITH HYPERKALEMIA. THE INITIAL CREATINE RESULT ON (B)(6) 2024 WAS 99.7 UMOL/L (REFERENCE RANGE: 57-110), POTASSIUM RESULT ON (B)(6) 2024 WAS 3.96 MMOL/L (NORMAL RANGE 3.5-5.3), AND THE DIALYSIS TREATMENT WAS CONSIDERED TO BE EFFECTIVE. THE PATIENT WAS RECOMMENDED FOR DISCHARGE AFTER SEVERAL DAYS OF OBSERVATION. UPON DISCHARGE, A NEW BLOOD SAMPLE WAS TAKEN TO TEST FOR CREATININE, AND THE CREATININE RESULT ON (B)(6) 2024 WAS 199 UMOL/L, POTASSIUM RESULT WAS ON (B)(6) 2024 WAS 3.79 MMOL/L. THE USER RETESTED THE SAMPLE FROM (B)(6) 2024 AND THE REPEAT CREATINE RESULT WAS 190 UMOL/L. THE CLINICAL PHYSICIAN THOUGHT THAT ABBOTT¿S CREATININE RESULT CAUSED DELAYS TO THE PATIENT¿S DIALYSIS TREATMENT. UPDATE: NEW INFORMATION WAS RECEIVED ON 23APR2024. THE FOLLOWING PATIENT RESULTS WERE PROVIDED: (B)(6) 2024: POTASSIUM 3.96 MMOL/L, SODIUM 144.7 MMOL/L, CHLORIDE 109.4 MMOL/L, CALCIUM 2.09 MMOL/L, MAGNESIUM 0.81 MMOL/L, INORGANIC PHOSPHORUS 0.96 MMOL/L, GLUCOSE 5.95 MMOL/L, GLYCATED HEMOGLOBIN (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059951 ↗
• MalfunctionMay 8, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT ON ONE PATIENT SAMPLE WHEN RUNNING ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: INITIAL CREATININE RESULT = 7.61 MG/DL; REPEAT ON ANOTHER ANALYZER = 0.78 MG/DL; REPEAT ON THE FIRST ANALYZER = 0.75 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16890854 ↗
• MalfunctionAug 30, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT WITH ALLERGIC SHOCK AND CORTISOL ADMINISTRATION. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 SID (B)(6) INITIAL RESULT WAS 29.95 MG/DL, REPEATED 29.95 MG/DL. A NEW SAMPLE WAS DRAWN SID (B)(6) AND THE RESULTS WERE 0.65 AND 0.63 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324395 ↗
• MalfunctionMay 11, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY INCREASED CREATININE RESULT GENERATED ON THE ARCHITECT C16000 ANALYZER ON A PATIENT. RESULTS PROVIDED: ON (B)(6) 2022 SID (B)(4) (NORMAL RANGE: 0.6-1.3 MG/DL). SERUM SAMPLE: SN# (B)(4) = 2.8 MG/DL, SN# (B)(4) = 2.8 MG/DL. PREVIOUS RESULT FOR THIS PATIENT = 0.9 MG/DL, (B)(6) LABS (ROCHE PLATFORM) = 0.9 MG/DL PLASMA SAMPLE DRAWN AT SAME TIME = 0.9 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14360445 ↗
• MalfunctionJul 19, 2021High Test Results; High Test Results

  A PHYSICIAN COMPLAINED THAT ARCHITECT CREATININE RESULTS WERE TOO HIGH. THE SAMPLES WERE RETESTED AND THE VALUES WERE LOWER. THE FOLLOWING EXAMPLES WERE PROVIDED. SID (B)(6): INITIAL RESULT 2.00 MG/DL, REPEAT RESULT 1.44 MG/DL. SID (B)(6): INITIAL RESULTS 2.13 AND 2.15 MG/DL, REPEAT RESULTS 1.59 AND 1.60 MG/DL. SID (B)(6): INITIAL RESULT 2.11 MG/DL, REPEAT RESULT 1.52 MG/DL. SID (B)(6): INITIAL RESULT 2.10 MG/DL, REPEAT RESULT 1.50 MG/DL. SID (B)(6): INITIAL RESULT 2.01 MG/DL, REPEAT RESULT 1.45 MG/DL. SID (B)(6): INITIAL RESULT 2.03 MG/DL, REPEAT RESULT 1.48 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12192819 ↗
• InjuryFeb 9, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULT ON ARCHITECT C8000 PROCESSING MODULE FOR ONE TRANSPLANT PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL CREATININE=10.6 MG/DL /REPEATED ON (B)(6) 2021=1.5 MG/DL. LABORATORY REFERENCE RANGE FOR CREATININE=0.6 MG/DL TO 1.1 MG/DL. THE PATIENT WAS ADMITTED INTO HOSPITAL AND PHYSICIAN PERFORMED PROCEDURES ON PATIENT DUE TO FALSELY ELEVATED CREATININE RESULT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED BY CUSTOMER REGARDING TREATMENT OR MEDICATION FOR PATIENTS. THERE WAS NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11303137 ↗
• MalfunctionJan 4, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED POTASSIUM AND CREATININE RESULTS GENERATED ON THE ARCHITECT C16000 ANALYZER ON A (B)(6) MALE PATIENT. RESULTS PROVIDED: (B)(6) 2020. (B)(6). POTASSIUM = 6.8 / 6.7 MMOL/L, NEW ALIQUOT = 4.6 MMOL/L (NORMAL RANGE: 3.5-5.1 MMOL/L); CREATININE = 451.6 UMOL/L, NEW ALIQUOT = 103.1 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11108722 ↗