ARCHITECT 3L81-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380740005993), received between Apr 6, 2017 and Nov 15, 2019 — classified as 15 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CREATININE RESULT GENERATED ON THE ARCHITECT C16000 FOR 1 SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) INITIAL RESULT = 233 UMOL/L, NEW SAMPLE WAS COLLECT = 55 UMOL/L, ORIGINAL SAMPLE WAS REPEAT = 66 UMOL/L.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9329185 ↗
• MalfunctionOct 7, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED CREATININE RESULT WHEN PROCESSING ON THE ARCHITECT C16000. THE INITIAL RESULT ON (B)(6) WAS 4.86 MG/DL AND RETEST RESULTS WERE 1.03, 1.00, AND 1.02. RETEST ON ANOTHER ANALYZER WAS 0.94 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9162101 ↗
• MalfunctionJul 29, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE RESULTS GENERATED ON THE ARCHITECT ANALYZER ON THREE PATIENTS. RESULTS PROVIDED: ON (B)(6) 2019: SID (B)(6) ((B)(6) YR. OLD MALE) = 4.9 / 1.0 MG / DL; SID (B)(6) ((B)(6) YR. OLD FEMALE) = 4.5 / 0.7 MG / DL; SID (B)(6) ((B)(6) YR. OLD MALE) = 6.3 / 1.5 MG / DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8837622 ↗
• MalfunctionJul 16, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CREATININE RESULTS ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED FOR A (B)(6)-YEAR OLD MALE PATIENT: SID (B)(6) INITIAL 4.43, REPEATED WITH A NEW SAMPLE ONE HOUR LATER AS 0.93 MG/DL. ORIGINAL SAMPLE WAS RERUN AS 1.03 MG/DL. THE PATIENT WAS ADMITTED FOR OBSERVATION, HOWEVER NO TREATMENT WAS PROVIDED AND NO NEGATIVE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8795213 ↗
• MalfunctionMay 9, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE RESULTS ON ONE PATIENT ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: SID (B)(6) ON (B)(6) 2019 CREATININE = 793 / 762 / 753UMOL/L; NEW SAMPLE ON (B)(6) 2019 CREAT = 96.9UMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8594909 ↗
• MalfunctionSep 25, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CREATININE RESULT WHILE USING CLINICAL CHEMISTRY CREATININE ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA (PROVIDED CUTOFF VALUE: 09.MG/DL): ON (B)(6) 2018: INITIAL: 3.10 MG/DL, RETEST 1.05 MG/DL, RETESTED ON A SECOND ANALYZER: 1.07 MG/DL . THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7906425 ↗
• MalfunctionJun 27, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT CREATININE RESULT. SAMPLE (B)(6) GENERATED AN INITIAL RESULT OF 7.4 MG/DL AND REPEAT GENERATED 0.9 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7642272 ↗
• MalfunctionDec 20, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER OBSERVED IMPRECISE CREATININE RESULTS WHILE USING THE CLINICAL CHEMISTRY CREATININE REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) INITIAL 1.74, REPEAT 2.88, 2.69, 2.91 MG/DL, SID (B)(6) INITIAL 1.05, REPEAT 2.24 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7135418 ↗
• MalfunctionOct 31, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT ON ONE MALE PATIENT WHICH WAS QUESTIONED BY THE PHYSICIAN. THE RESULTS PROVIDED WERE: (B)(6) INITIAL = 6.78 MG/DL (NORMAL RANGE 0.7-1.3 MG/DL). THE PATIENT HAD A KIDNEY ULTRASOUND WITHOUT IV CONTRAST AND A URINALYSIS, WHICH WERE BOTH NORMAL. A NEW SAMPLE DRAWN ((B)(6)) GENERATED RESULTS OF 1.06 / 1.09 MG/DL. THE ORIGINAL SAMPLE WAS RETESTED = 1.01 / 1.04 / 1.01 MG/DL AND THE ORIGINAL RESULT WAS CORRECTED TO 1.01 MG/DL. THERE WAS NO ADVERSE IMPACT TO THE PATIENT REPORTED. THE PATIENT RECEIVED NO ADDITIONAL TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6989909 ↗
• MalfunctionOct 17, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS GENERATED USING THE ARCHITECT CLINICAL CHEMISTRY CREATININE REAGENTS. THE FOLLOWING DATA WAS PROVIDED (MG/DL). (B)(6) (TESTED IN (B)(6) 2016) INITIAL 2.1, RETEST 1.5, 1.5. ADDITIONAL UNOPENED SPECIMEN RETEST 0.9, 0.9. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6955860 ↗
• MalfunctionJun 8, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS GENERATED USING THE ARCHITECT CLINICAL CHEMISTRY CREATININE REAGENTS. THE FOLLOWING DATA WAS PROVIDED (MG/DL). SID (B)(6) (TESTED IN (B)(6) 2016) INITIAL 2.1, RETEST 1.5, 1.5. ADDITIONAL UNOPENED SPECIMEN RETEST 0.9, 0.9. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6623691 ↗
• MalfunctionMay 26, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE PRODUCT EVALUATION, CLOSED ON MAY 15, 2017, DETERMINED THAT A MALFUNCTION WAS IDENTIFIED, WHICH IMPACTS THE PREVIOUS REPORTABILITY DECISION. THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE RESULTS FOR ONE PATIENT GENERATED USING THE CLINICAL CHEMISTRY CREATININE REAGENTS. THE FOLLOWING DATA WAS PROVIDED (MG/DL). SID (B)(6) INITIAL 7.60, REPEAT 0.7. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6595420 ↗
• MalfunctionMay 25, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER STATED THAT A PATIENT HAD FALSELY ELEVATED CREATININE RESULTS GENERATED USING THE CLINICAL CHEMISTRY CREATININE REAGENTS. THE FOLLOWING DATA WAS PROVIDED IN MG/DL. INITIAL 4.59. REPEAT RESULTS USING A SAMPLE FROM THE SAME PATIENT SHOWED NORMAL RESULTS, HOWEVER NO SPECIFIC VALUES WERE PROVIDED FOR THE REPEAT TESTS. NORMAL RANGE IS LESS THAN 1.25. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6593013 ↗
• MalfunctionMay 16, 2017High Test Results; High Test Results

  THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY ELEVATED CREATININE RESULTS ON ONE ONCOLOGY DEPARTMENT PATIENT IN (B)(6) 2016. THE RESULTS PROVIDED WERE: INITIAL = 4.7 / REPEATED = 1.5 (NORMAL RANGE 0.7-1.2). THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6569269 ↗
• MalfunctionApr 6, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CREATININE RESULT WHILE USING CLINICAL CHEMISTRY CREATININE ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA (CUSTOMER PROVIDED REFERENCE RANGE 0.72-1.25 MG/DL): INITIAL RESULT: 5.58 MG/DL. THE PATIENT WAS REDRAWN PER THE PHYSICIANS REQUEST AND A RESULT OF 1.05 MG/DL WAS GENERATED. THE ORIGINAL SPECIMEN WAS RETESTED GENERATING THE FOLLOWING RESULTS: 1.0, 1.04 AND 1.03 MG/DL DUE TO THE ELEVATED RESULT THE PATIENT WAS INSTRUCTED TO DISCONTINUE TAKING THE MEDICATION METFORMIN. THE PATIENT RESUMED TAKING THEIR MEDICATION ONE DAY LATER. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6463558 ↗