ARCHITECT 3L81-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00380740005979), received between Dec 9, 2016 and Jul 14, 2021 — classified as 31 malfunctions.

The most frequently reported specific device problem is “High Test Results” (27 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CREATININE RESULT GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT WITH KIDNEY FAILURE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 0.39 MG/DL, REPEAT = 15.75 MG/DL, REPEAT ON ANOTHER ARCHITECT = 15.79 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166290 ↗
• MalfunctionJul 28, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED CREATININE RESULT ON THE ARCHITECT C8000 PROCESSING MODULE FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2020 SID (B)(6) = INITIAL RESULT = 2.51 MG/DL, ON (B)(6) 2020 RESULT = 0.70 MG/DL(NEW PATIENT SAMPLE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10335171 ↗
• MalfunctionApr 8, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR A (B)(6) YEAR OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 62 TO 120 UMOL/L): ON (B)(6) 2020; SID: (B)(6); INITIAL RESULT = 183.8 UMOL/L, REPEAT = 186.3 UMOL/L, REPEAT ON COBAS = 85.1 UMOL/L, REPEAT ON (B)(6) 2020 = 75 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9938987 ↗
• MalfunctionFeb 11, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2020 SID (B)(6) = 3.8 MG/DL, ANOTHER LABORATORY = 1.4 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9694809 ↗
• MalfunctionDec 12, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED CREATININE RESULT WHEN PROCESSING ON THE ARCHITECT C8000. THE INITIAL RESULT WAS 10.98 AND RETEST RESULT WAS 0.98. THE CUSTOMER USES A REFERENCE RANGE OF 0.72-1.25 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9458141 ↗
• MalfunctionOct 31, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY INCREASED CREATININE RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2019 SID (B)(6) = 3.27 / 3.27 MG/DL; NEW SAMPLE COLLECTED = 0.94 / 0.89 MG/DL. OTHER RESULTS PROVIDE: BUN = 11 MG/DL ON BOTH SAMPLES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9259538 ↗
• MalfunctionSep 16, 2019High Test Results; Low Test Results; High Test Results; Low Test Results

  THROUGH THE PRODUCT QUALITY INVESTIGATION IT WAS DISCOVERED THAT THE ARCHITECT CREATININE OF 4.46 AND 4.11 MG/DL ARE THE CORRECT RESULTS AND 0.66 MG/DL RESULT IS A FALSE DEPRESSED RESULT. INITIALLY THE PATIENT GENERATED ARCHITECT CREATININE OF 4.46, 4.11 MG/DL BUT THE RESULTS WERE QUESTIONED. THE PATIENT WAS TESTED AGAIN WITH ARCHITECT CREATININE OF 0.66 MG/DL. THROUGH TROUBLESHOOTING, IT WAS DETERMINED THAT THE ARCHITECT CREATININE OF 0.66 MG/DL WAS A FALSE DEPRESSED RESULT AND THE ARCHITECT CREATININE OF 4.46, 4.11 MG/DL WERE THE CORRECT RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9073278 ↗
• MalfunctionSep 16, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CREATININE RESULT. SAMPLE ID (B)(6) GENERATED INITIAL 201 UMOL/L AND RETEST 104 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9071796 ↗
• MalfunctionAug 26, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED CREATININE RESULTS WHEN PROCESSING ON THE ARCHITECT C8000. THE FOLLOWING DATA WAS PROVIDED: CREATININE: INITIAL RESULT WAS 4.3 AND RETEST WAS 0.5 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8931976 ↗
• MalfunctionJun 11, 2019High Test Results; High Test Results

  A PHYSICIAN QUESTIONED A FALSELY ELEVATED ARCHITECT CREATININE RESULT OF 2.99 MG/DL (SID (B)(6)). A NEW SAMPLE WAS COLLECTED FROM THE SAME PATIENT (SID (B)(6)) AND THE ARCHITECT CREATININE RESULT WAS 0.87 MG/DL. BOTH SAMPLES WERE RETESTED AND RESULTS WERE 1.12 AND 0.85 MG/DL RESPECTIVELY. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8688244 ↗
• MalfunctionJun 10, 2019High Test Results; High Test Results

  A PHYSICIAN QUESTIONED A FALSELY ELEVATED ARCHITECT CREATININE RESULT OF 2.254 MG/DL THAT RETESTED AT 1.144 AND 1.152 MG/DL. THE PATIENT WAS REDRAWN AND THE CREATININE RESULT WAS 0.9 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8683450 ↗
• MalfunctionApr 17, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CREATININE RESULT. THE SAMPLE GENERATED AN INITIAL RESULT OF 14.6 MG/DL AND RETEST ON THE ORIGINAL AND ALTERNATE ANALYZER GENERATED 0.8 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8524692 ↗
• MalfunctionApr 9, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 2.91, REPEAT 0.87, 0.87 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8497343 ↗
• MalfunctionFeb 20, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED CREATININE RESULTS ON THE ARCHITECT ANALYZER FOR ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) ON (B)(6) 2018 = 25.86MG/L (2.59MG/DL)/ REPEAT = 25.36MG/L (2.54MG/DL) / REPEATED ON (B)(6) 2018 = 24.23MG/L (2.42MG/DL) / SAMPLE SENT TO ANOTHER SITE WITH AN ARCHITECT AND THE RESULT WAS NORMAL. THE PATIENT RETURNED ON (B)(6) 2019, SID (B)(6) = 7.14MG/L (0.71MG/DL) / 6.93MG/L (0.69MG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8355748 ↗
• MalfunctionJan 31, 2019High Test Results; High Test Results

  THE CUSTOMER STATED THAT DISCREPANT ARCHITECT CREATININE RESULTS OF 5.66 AND 0.84 MG/DL WERE GENERATED FOR A (B)(6) FEMALE PATIENT (SAMPLE ID (B)(6)). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8294407 ↗
• MalfunctionJan 14, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED ARCHITECT CREATININE RESULTS FROM A PATIENT SAMPLE. THE INITIAL RESULT WAS 6.72 MG/DL AND REPEAT RESULTS (SAME INSTRUMENT) WERE 6.72 AND 6.63 MG/DL. THE CUSTOMER USES A REFERENCE RANGE OF 0.57-1.25 MG/DL. AS A RESULT, THE PATIENT WAS SENT FOR A REDRAW AND REPEAT TESTING WAS NORMAL (NO SPECIFIC RESULT PROVIDED). NO OTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE CUSTOMER REPORTED THERE WERE NO ISSUES WITH SAMPLE COLLECTION/HANDLING NOR WITH SAMPLE INTEGRITY AND THAT OTHER ASSAYS WERE PERFORMED ON THE SAME SAMPLE WITHOUT ANY ISSUE. AN ALIQUOT OF THE ORIGINAL SAMPLE WAS SENT TO (B)(6) FOR TESTING (COBAS 710 INSTRUMENT, CREATININE JAFFE METHOD) AND YIELDED A RESULT OF 2.646. ADDITIONAL TESTING (EX. BUN) CORRELATED WITH THE CREATININE REDRAW NORMAL RESULT, PATIENT HISTORY AND PREVIOUSLY REPORTED RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8245463 ↗
• MalfunctionJan 7, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS WHILE USING CLINICAL CHEMISTRY CREATININE REAGENTS. THE CUSTOMER USES REFERENCE RANGE 0.57 TO 1.11 MG/DL. PATIENT 1 (NO SID PROVIDED) SPECIMEN 1 INITIAL 5.9 MG/DL, REPEAT 0.70 MG/DL; SPECIMEN 2 INITIAL 0.72 MG/DL PATIENT 2 (SID (B)(6)) SPECIMEN 1 INITIAL 7.82 MG/DL, REPEAT 0.55 MG/DL; SPECIMEN 2 0.55 MG/DL PATIENT 3 (SID (B)(6)) INITIAL 7.95 MG/DL, REPEAT 0.77 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8224218 ↗
• MalfunctionDec 3, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED ARCHITECT CREATININE RESULTS FROM A PATIENT SAMPLE. THE INITIAL RESULT WAS 6.72 MG/DL AND REPEAT RESULTS (SAME INSTRUMENT) WERE 6.72 AND 6.63 MG/DL. THE CUSTOMER USES A REFERENCE RANGE OF 0.57-1.25 MG/DL. AS A RESULT, THE PATIENT WAS SENT FOR A REDRAW AND REPEAT TESTING WAS NORMAL (NO SPECIFIC RESULT PROVIDED). NO OTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE CUSTOMER REPORTED THERE WERE NO ISSUES WITH SAMPLE COLLECTION/HANDLING NOR WITH SAMPLE INTEGRITY AND THAT OTHER ASSAYS WERE PERFORMED ON THE SAME SAMPLE WITHOUT ANY ISSUE. AN ALIQUOT OF THE ORIGINAL SAMPLE WAS SENT TO LABCORP FOR TESTING (COBAS 710 INSTRUMENT, CREATININE JAFFE METHOD) AND YIELDED A RESULT OF 2.646. ADDITIONAL TESTING (EX. BUN) CORRELATED WITH THE CREATININE REDRAW NORMAL RESULT, PATIENT HISTORY AND PREVIOUSLY REPORTED RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8126516 ↗
• MalfunctionNov 16, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS WHILE USING CLINICAL CHEMISTRY CREATININE REAGENTS. THE FOLLOWING DATA WAS PROVIDED. THE CUSTOMER USES NORMAL RANGE 0.5 TO 1.4 MG/DL. SID (B)(6) INITIAL 2.8 MG/DL, REPEAT 0.89, 0.92 MG/DL. A PRECISION STUDY USING THE PATIENT SPECIMEN SHOWED VALUES FROM 0.86 TO 0.90 MG/DL. DUE TO THE FIRST ELEVATED VALUE, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL UNDER SUSPICION OF RENAL FAILURE. NO TREATMENT WAS REPORTED FOR THE PATIENT. DURING TESTING AT THE OTHER HOSPITAL, THE PATIENT CREATININE VALUE WAS NORMAL, HOWEVER NO SPECIFIC VALUE OR METHOD WERE PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8081557 ↗
• MalfunctionNov 2, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT A CLINICAL CHEMISTRY CREATININE RESULT OF 4.0 MG/DL WAS GENERATED FOR A PATIENT SAMPLE TESTED ON THE ARCHITECT C8000 SYSTEM. THE SAME SAMPLE TESTED AT 2.0 AND 1.9 MG/DL USING ALTERNATE CREATININE METHODS. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8035122 ↗
• MalfunctionOct 8, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATININE RESULTS ON THE ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 6.7, REPEAT 0.88, 0.77, 1.0, 0.8, 1.0 MG/DL. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION, HAD ADDITIONAL BLOOD DRAWS, AND WAS CAUSED UNDUE STRESS DUE TO THE FALSELY ELEVATED RESULT. HOWEVER, NO NEGATIVE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7945231 ↗
• MalfunctionApr 23, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT AN INITIAL CREATININE RESULT OF 2.3 MG/DL WAS GENERATED ON THE ARCHITECT C4000 ANALYZER. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. A NEW SAMPLE WAS OBTAINED AND A RESULT OF 1.0 MG/DL WAS GENERATED. THE CUSTOMER REPEATED BOTH SAMPLES AND RESULTS OF 1.0 AND 1.1 MG/DL WERE GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7452974 ↗
• MalfunctionMar 15, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT CREATININE RESULT OF 6.7 MG/DL WAS GENERATED FOR A PATIENT SAMPLE (ID (B)(6)) THAT RETESTED AT 1.455 MG/DL. THE CUSTOMER'S REFERENCE RANGE IS 0.72 TO 1.25 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7341986 ↗
• MalfunctionJun 15, 2017High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSELY ELEVATED ARCHITECT CREATININE OF 2.93 MG/DL ON SAMPLE ID (B)(4) THAT REPEATED 0.90 MG/DL. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6643041 ↗
• MalfunctionMay 10, 2017High Test Results; High Test Results

  THE ACCOUNT GENERATED A FALSELY ELEVATED ARCHITECT CREATININE RESULTS OF 2.25 AND 2.20 MG/DL ON A SAMPLE THAT TESTED BECKMAN AU480 CREATININE METHOD OF 1.17 MG/DL. THE SAMPLE WAS OBTAINED AFTER THOMBOLYSIS TREATMENT. THE PRE-TREATMENT SAMPLE GENERATED ARCHITECT CREATININE OF 1.33 MG/DL AND BECKMAN ENZYMATIC METHOD OF 1.39 MG/DL. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6557029 ↗