ARCHITECT 04S9520Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740159535), received between May 2, 2024 and Jan 9, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJan 9, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE2 RESULTS GENERATED BY THE ARCHITECT C8000 PROCESSING MODULE FOR A PATIENT. A NEW BLOOD SAMPLE WAS DRAWN AND YIELD A NORMAL RESULT. THE FOLLOWING DATA WAS PROVIDED: NORMAL REFERENCE RANGES: CREATININE2: 0.60 TO 1.30 MG/DL. SID (B)(6): 29DEC2025 CREATININE2 INITIAL RESULT = 7.84 MG/DL, REPEAT RESULTS ((B)(6) 2025) = 2.67 AND 2.69 MG/DL. SID (B)(6) (NEW BLOOD DRAW FOR THE SAME PATIENT): (B)(6) 2025 CREATININE2 RESULT = 0.68 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019256 ↗
• MalfunctionSep 19, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE2 ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE PATIENT WAS TAKING MEDICATIONS NOVALGINA AND DECADRON. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE, CREATININE 0.60 MG/DL - 1.10 MG/DL): (B)(6) 2024, SID (B)(6), INITIAL CREATININE RESULT (ANALYZER (B)(6) )= 10.67 MG/DL; REPEAT RESULT (ANALYZER (B)(6) )= 10.36 MG/DL; FROM A SECOND BLOOD COLLECTION, SID (B)(6), CREATININE RESULT (ANALYZER (B)(6) )= 0.69 MG/DL; FROM A THIRD BLOOD COLLECTION, SID (B)(6), CREATININE RESULT (ANALYZER (B)(6) )= 0.73 MG/DL. THE CUSTOMER REPORTED THAT THE INITIAL CREATININE RESULTS WERE FROM BLOOD DRAWN FROM THE SAME LIMB THAT IV MEDICATION WAS BEING ADMINISTERED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255977 ↗
• MalfunctionJun 19, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A DISCREPANT CREATININE2 RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER ON A PATIENT. RESULTS PROVIDED: PT 4 (56-YR OLD FEMALE) = 1.88 / 5.02 / 4.02 / 4.96 / 4.98 / 5.09 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565762 ↗
• MalfunctionMay 2, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CREATININE2 RESULT GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE SAMPLE THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL RESULT = 0.59 MG/D, REPEAT = 2.67 MG/DL . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231634 ↗