ARCHITECT 6L45-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00380740011369), received between Mar 24, 2017 and Apr 11, 2023 — classified as 46 malfunctions.

The most frequently reported specific device problem is “High Test Results” (31 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER NORMAL RANGE 0.2-1.2 MG/DL). PT (B)(6) CAME INTO ER ON (B)(6) 2023 INITIAL RESULT = 4.5 MG/DL. PT (B)(6) WENT HOME AND THE DOCTOR CALLED AND QUESTIONED RESULT. THE DOCTOR HAD THE PATIENT COME BACK IN TODAY FOR REDRAW AND RESULTS = 0.6 MG/DL,0.6 MG/DL. THE CUSTOMER THEN PULLED SAMPLE FROM (B)(6) 2023 RERAN RESULT= 0.8 MG/DL. THE CUSTOMER REPORTED NO INCORRECT TREATMENT GIVEN OR WITHHELD BASED ON INITIAL RESULT; HOWEVER, EXTRA HEPATITIS TESTING WAS ADDED DUE TO RESULT. CUSTOMER THEN PROCEEDED WITH RERUNNING OTHER SAMPLES AND FOUND MORE DISCREPANT RESULTS: ADDITIONAL RESULTS WERE PROVIDED: SID (B)(6) RESULT= 3.2 MG/DL, REPEAT RESULT =1.20 MG/DL. SID (B)(6) RESULT=2.8 MG/DL, REPEAT RESULT=0.5 MG/DL. SID (B)(6) RESULT= 2.3 MG/DL, REPEAT RESULT= 0.8 MG/DL. SID (B)(6) RESULT= 4.0 MG/DL, REPEAT RESULT= 0.3 MG/DL. SID (B)(6) RESULT=4.0 MG/DL, REPEAT RESULT= 0.6 MG/DL. SID (B)(6) RESULT=4.8 MG/DL, REPEAT RESULT=0.60 MG/DL. SID (B)(6) RESULT=5.2 MG/DL, REPEAT RESULT= 0.30 MG/DL. SID (B)(6) RESULT=4.0 MG/DL, REPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715878 ↗
• MalfunctionMar 7, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR MULTIPLE NEWBORN PATIENTS. THE RESULTS OF THE TOTAL BILIRUBIN DIDN¿T MATCH THE DEGREE OF NEONATAL JAUNDICE. THE SAMPLES WERE REPEATED WITH SIEMENS¿ INSTRUMENTATION AND ABBOTT¿S RESULTS WERE 20-30% HIGHER. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: SAMPLE 1: ARCHITECT RESULT = 339 UMOL/L, SIEMENS¿ RESULT = 264 UMOL/L SAMPLE 2: ARCHITECT RESULT = 180 UMOL/L, SIEMENS¿ RESULT = 146 UMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497641 ↗
• MalfunctionJul 13, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 3.4 TO 20.5 UMOL/L): SID 5225 INITIAL RESULT = 104.2 UMOL/L, REPEAT ON C1601866 = 18.1 UMOL/L, SID 5267 INITIAL RESULT = 116.4 UMOL/L, REPEAT ON C1601866 = 10.5 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15000550 ↗
• MalfunctionDec 20, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED TOTAL BILIRUBIN RESULT FOR A PREGNANT FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 0.3-1.2 MG/DL): INITIAL RESULT WAS 0.2, REPEAT WAS 0.4 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047845 ↗
• MalfunctionJun 10, 2021High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS WERE GENERATED FOR A PATIENT ON THE ARCHITECT C4000 ANALYZER. THE CUSTOMER STATED THAT SID (B)(6) GENERATED A RESULT OF 372.6 UMOL/L. AN HOUR LATER, THE CUSTOMER STATED A NEW SAMPLE WAS OBTAINED FROM THE PATIENT SID (B)(6) WHICH GENERATED A RESULT OF 232.5 UMOL/L (SHIFT OF 60.26%). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11974710 ↗
• MalfunctionMar 5, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS ON ARCHITECT C4000 PROCESSING MODULE FOR TWO PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2021 SID (B)(6) INITIAL BILIRUBIN=19.15 UMOL/L /REPEATED=9.18 UMOL/L. SID (B)(6) INITIAL BILIRUBIN=15.9 UMOL/L /REPEATED=5.9 UMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11425466 ↗
• MalfunctionFeb 7, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C8000 ON ONE PATIENT. RESULTS PROVIDED: SID (B)(6) = (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11290411 ↗
• MalfunctionJan 25, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED TOTAL BILIRUBIN RESULTS FOR SEVERAL PATIENTS ON AN ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 0.20-1.20 MG/DL): SAMPLE ID (B)(6) INITIAL RESULT WAS <0.2, REPEAT WAS 0.55 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS <0.2, REPEAT WAS 0.40 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS <0.2, REPEAT WAS 0.33 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS 0.79, REPEAT WAS 1.40 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS 0.64, REPEAT WAS 1.24 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS <0.2, REPEAT WAS 0.59 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS <0.2, REPEAT WAS 0.32 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS <0.2, REPEAT WAS 0.48 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS <0.2, REPEAT WAS 0.30 MG/DL. SAMPLE ID (B)(6) INITIAL RESULT WAS 0.35, REPEAT WAS 0.95 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11227009 ↗
• MalfunctionNov 30, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TOTAL BILIRUBIN RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL RESULT BILIRUBIN, TOTAL = >25.00 MG/DL, REPEATED BILIRUBIN, TOTAL = 1.30 MG/DL, REPEATED ON THE ALINITY BILIRUBIN, TOTAL = 23.17 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10924503 ↗
• MalfunctionNov 24, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TOTAL BILIRUBIN RESULTS ON A (B)(6)-YEAR-OLD FEMALE PATIENT. THE RESULTS GENERATED ON (B)(6) 2020 WERE: SID: (B)(6); INITIAL RESULT = 150.5 UMOL/L, RETESTED ON ANOTHER INSTRUMENT = 14 UMOL/L (REFERENCE RANGE: <30UMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10899176 ↗
• MalfunctionNov 13, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSE DECREASED TOTAL BILIRUBIN RESULTS FOR 2 PATIENT SAMPLES WHILE RUNNING ON THE ARCHITECT C8000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED ON (B)(6) 2020 (REFERENCE RANGE: 0.2-1.2 MG/DL): SAMPLE 1 = INITIAL = 0.13 MG/DL; REPEAT RESULT = 0.74 MG/DL. SAMPLE 2 = INITIAL = <0.10 MG/DL; REPEAT RESULT = 0.94 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10838627 ↗
• MalfunctionNov 4, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED DIRECT BILIRUBIN RESULTS WHEN COMPARE TO TOTAL BILIRUBIN ON ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: TOTAL BILIRUBIN ON ARCHITECT=1.7 MG/DL/ REPEATED ON SAME ANALYZER=1.6 MG/DL/ REPEATED ON ALINITY=2.07 MG/DL/ REPEATED ON SIEMENS EXL=2.6 MG/DL LABORATORY REFERENCE RANGE FOR ARCHITECT TOTAL BILIRUBIN=0.2 MG/DL TO 1.2 MG/DL LABORATORY REFERENCE RANGE FOR EXL TOTAL BILIRUBIN=0.2 MG/DL TO 1.0 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10786914 ↗
• MalfunctionOct 14, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS ON ARCHITECT C16000 PROCESSING MODULE FOR ONE PEDIATRIC PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2020, SID: (B)(6); INITIAL TOTAL BILIRUBIN=22.29 MG/DL/ REPEATED ON ALINITY=21 MG/DL AND 20 MG/DL/ REPEATED ON ROCHE INSTRUMENT=15.5 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10678182 ↗
• MalfunctionAug 18, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED TOTAL BILIRUBIN RESULT FOR ONE PATIENT ON AN ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2020, WAS 25.2 UMOL/L, WHICH WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE MEDICAL PROVIDER. THE SAMPLE WAS THEN REPEATED IN ANOTHER LABORATORY, USING AN ALINITY C ANALYZER, AND THE RESULT WAS 9.0 UMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10422858 ↗
• MalfunctionAug 10, 2020Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TOTAL BILIRUBIN RESULTS FOR PATIENT SAMPLES. ONE EXAMPLE WAS PROVIDED. AN INITIAL RESULT OF 0.1 MG/DL RETESTED AT 0.4 MG/DL MULTIPLE TIMES. THE NORMAL RANGE FOR THIS PATIENT IS 0.2 - 1.2 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10386008 ↗
• MalfunctionJul 20, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: 6 DAYS OLD: SID (B)(6) INITIAL RESULT = 245.2 UMOL/L, REPEAT WITH COBAS ROCHE = 180 UMOL/L NEW DRAW SPECIMEN: 7 DAYS OLD: SID (B)(6) INITIAL RESULT = 274.4 UMOL/L, REPEAT WITH COBAS ROCHE = 224 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10298907 ↗
• MalfunctionJul 13, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED TOTAL BILIRUBIN RESULT FOR ONE PATIENT ON AN ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2020, WAS 25.2 UMOL/L, WHICH WAS REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE MEDICAL PROVIDER. THE SAMPLE WAS THEN REPEATED IN ANOTHER LABORATORY, USING AN ALINITY C ANALYZER, AND THE RESULT WAS 9.0 UMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10267950 ↗
• MalfunctionMay 16, 2020Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED FALSELY DEPRESSED ARCHITECT TOTAL BILIRUBIN RESULTS. THE CUSTOMER USES AN ADULT NORMAL RANGE OF 0.2 TO 1.2 MG/DL. SAMPLE ID (B)(6) FOR A (B)(6) YEAR OLD FEMALE: (B)(6) 2020 1.12 MG/DL; PATIENT'S PREVIOUS RESULT (B)(6) 2018 1.50 MG/DL. NO IMPACT TO PATIENT MANAGMEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10063961 ↗
• MalfunctionApr 17, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C4000 ON A (B)(6) INFANT. RESULTS PROVIDED: (B)(6) 2020 SID (B)(6) = > 25 MG/DL; MANUAL X 10 DILUTION = 67.86 MG/DL; NEW SAMPLE SENT TO REFERENCE LABORATORY = 19.1 / 22.0 MG/DL; RE-RAN INITIAL SAMPLE X10 DILUTION = 26.84 MG/DL. NORMAL RANGE: 0-11.6 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9972614 ↗
• MalfunctionFeb 25, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN ON ARCHITECT C16000 ANALYZER FOR MULTIPLE PATIENT SAMPLES. THE RESULTS WERE PROVIDED: ON (B)(6) INITIAL =82.92/REPEAT=12.02(CUSTOMER REFERENCE RANGE=3.4-20.5 UMOL/L), SID (B)(6) INITIAL=348.72/REPEAT=16.20, SID (B)(6) INITIAL=98.83/REPEAT=7.87, SID (B)(6) INITIAL=94.52/REPEAT=8.06, SID (B)(6) INITIAL=85.99/REPEAT=6.89, SID (B)(6) INITIAL=225.53/REPEAT=24.46, SID (B)(6) INITIAL =169.75/REPEAT=6.00, SID (B)(6) INITIAL= 78.45/REPEAT=11.84, SID (B)(6) INITIAL=248.26/REPEAT=14.65. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9752771 ↗
• MalfunctionJan 10, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED TOTAL BILIRUBIN RESULTS WHEN PROCESSING ON THE ARCHITECT C16000. THE FOLLOWING INITIAL AND RETEST DATA WAS PROVIDED: 18.1 (INITIAL) AND 12.6 (RETEST). 53.5 (INITIAL) AND 40.8 (RETEST). 5.3 (INITIAL) AND 3.7 (RETEST). 25 (INITIAL) AND 19.6 (RETEST). THE CUSTOMER USES A REFERENCE RANGE OF 3.4-20.5 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9573658 ↗
• MalfunctionDec 27, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C4000 ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2019 = 21.9 MG/DL / (B)(6) = 16.9 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9525651 ↗
• MalfunctionDec 16, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED BILIRUBIN ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED FOR A NEONATE: INITIAL 22.47, REPEATED 16 MG DL. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, HOWEVER NO NEGATIVE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9473554 ↗
• MalfunctionOct 28, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED NEONATAL TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2019 ARCHITECT VITROS ALINITY. SID (B)(6) DRAWN 1004 = 18.2 /16.0 /16.7. SID (B)(6) DRAWN 1635 = 18.3 / 15.6 /16.7. SID (B)(6) DRAWN 2315 = 19.4 / 16.0 / 17.5 / REPEAT ON ARCHITECT = 19.5. NORMAL RANGE: 0.2 TO 12.0 MG/DL. SISTER HOSPITAL VITROS RESULT ON (B)(6) 2019 = 13.4 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9244234 ↗
• MalfunctionMay 20, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS WERE GENERATED FOR NEONATES WHILE USING THE ARCHITECT C461216 ANALYZER. THE FOLLOWING RESULTS WERE PROVIDED: SID: (B)(6) - ARCHITECT: 17.8 MG/DL; ALTERNATE METHOD: 13.9 MG/DL (% SHIFT = 28%). SID: (B)(6) - ARCHITECT: 10.2 MG/DL; ALTERNATE METHOD: 8.3 MG/DL (% SHIFT = 22.9%). THE CUSTOMER FURTHER STATED THAT SID: (B)(6) GENERATED AN ARCHITECT RESULT OF 15.2 MG/DL, WITH A ALTERNATE METHOD RESULT OF 12.3 MG/DL (% SHIFT = 23.6%); HOWEVER, THE CUSTOMER WAS NOT SURE IF THE ARCHITECT RESULT WAS GENERATED ON THE C461216 OR THE C401829 ANALYZER. THE CUSTOMER WAS UTILIZING A CRITICAL CUT OFF OF >/= 17 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8623836 ↗