ARCHITECT 3L81-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380740161552), received between Apr 29, 2021 and May 14, 2024 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: TESTED ON (B)(6) 2024 (CREATININE NORMAL RANGE: 0.5-1.5 MG/DL). SID (B)(6): CREATININE INITIAL RESULT = 2.125 MG/DL; CREATININE REPEAT RESULT = 0.800 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315569 ↗
• MalfunctionNov 16, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT FOR A PATIENT SAMPLE WHILE RUNNING ON THE ARCHTIECT C4000 PROCESSING MODULE. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM DUE TO THE ELEVATED CREATININE RESULT, HOWEVER NO KNOWN TREATMENT WAS PERFORMED BASED ON THE RESULT PROVIDED. LAB¿S REFERENCE RANGE FOR CREATININE: 0.7-1.25 MG/DL. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2022, SID (B)(6): INITIAL RESULT: 7.26 MMG/DL. RERUN ON THE SAME INSTRUMENT: 0.79, 0.80 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15810879 ↗
• MalfunctionMay 20, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL AND REPEAT RESULTS = 7.76 MG/DL, A NEW SAMPLE WAS COLLECTED WHICH GENERATED AN INITIAL RESULT OF 0.854 MG/DL AND REPEAT RESULT OF 0.887 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463356 ↗
• MalfunctionMay 11, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY INCREASED CREATININE RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER ON A PATIENT. RESULTS PROVIDED: 15APR2022 SID (B)(4) (NORMAL RANGE: 0.6-1.3 MG/DL), LOT# 09277UN21. SERUM SAMPLE: SN# (B)(4) = 2.9 / 2.9 MG/DL, SN# (B)(4) = 2.9 / 2.9 MG/DL, SN# (B)(4) = 2.8 MG/DL, SN# (B)(4) = 2.8 MG/DL. PREVIOUS RESULT FOR THIS PATIENT = 0.9 MG/DL. MAYO LABS (ROCHE PLATFORM) = 0.9 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14358009 ↗
• MalfunctionMay 5, 2022High Test Results; High Test Results

  THE CUSTOMER QUESTIONED CREATININE RESULTS GENERATED WITH THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING WAS PROVIDED BY THE CUSTOMER. SID (B)(6) RESULT 3.18 RERUN 0.84 MG/DL. CUSTOMER HAD A RENAL PANEL UNDER A DIFFERENT SID (SID (B)(6)) AND RESULT WAS CLOSE TO THE REPEATED RESULT. CUSTOMER STATED THE RESULT WAS CORRECTED TO 0.84 WHICH MATCHES PATIENT HISTORY. CUSTOMER NORMAL RANGE 0.70-7.20 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14290919 ↗
• MalfunctionApr 1, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CREATININE RESULTS WHICH QUESTIONED BY PHYSICIAN ON ONE FEMALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2022 SID (B)(6) INITIAL=2.99 MG/DL /REPEATED=0.77 MG/DL /REDRAWN AND REPEATED SID (B)(6) = 0.73 MG/DL . LABORATORY REFERENCE RANGE FOR CREATININE=0.57 TO 1.11 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978761 ↗
• MalfunctionJul 20, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 53 TO 100 UMOL/L): (B)(6) 2021 SID (B)(6) INITIAL RESULT = 263.8 UMOL/L, REPEAT = 263.8 UMOL/L, REPEAT ON ANOTHER ARCHITECT = 264.1 UMOL/L, ROCHE = 112.6 UMOL/L, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12195815 ↗
• MalfunctionApr 29, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE RESULTS ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: (B)(6). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11747992 ↗