ARCHITECT 6L45-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380740174972), received between Apr 20, 2021 and Aug 5, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Low 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.

• MalfunctionAug 5, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS FOR ONE SAMPLE. THE CUSTOMER STATED THAT THERE WAS INSTRUMENT ERROR MESSAGE ¿1051 UNABLE TO CALCULATE RESULT, ABSORBANCE EXCEEDED OPTICAL LIMITS¿ AND THE INSTRUMENT WHEN TO AUTO-DILUTION AND THE RESULT WAS REPORTED OUT OF THE LAB. THE FOLLOWING RESULT WAS PROVIDED: TOTAL BILIRUBIN: AUTO-DILUTION RESULT THAT WAS REPORTED OUT WAS <0.1 MG/DL, RERUN WAS 0.5 MG/DL (REFERENCE RANGE: 0.1-1.2 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715709 ↗
• MalfunctionJul 23, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED INCREASED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C8000 ANALYZER FOR 13 PATIENTS. THE CUSTOMER REPEATED THE SAMPLES ON ANOTHER ARCHITECT WHICH GENERATED LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL RESULT = 1.54 REPEAT RESULT = 0.59. SID (B)(6), INITIAL RESULT = 0.7 REPEAT RESULT = 0.3. SID(B)(6), INITIAL RESULT = 0.8 REPEAT RESULT = 0.4. SID(B)(6), INITIAL RESULT = 0.6 REPEAT RESULT = 0.3. SID (B)(6), INITIAL RESULT = 0.9 REPEAT RESULT = 0.4. SID (B)(6), INITIAL RESULT = 0.9 REPEAT RESULT = 0.4. SID (B)(6), INITIAL RESULT = 4.1 REPEAT RESULT = 1.6. SID (B)(6), INITIAL RESULT = 0.8 REPEAT RESULT = 0.5. SID(B)(6), INITIAL RESULT = 2.9 REPEAT RESULT = 1.2. ADULT REF RANGE 0.2-1.2 MG/DL. THE FOLLOWING SAMPLES ARE NEONATES REFERENCE RANGE IS 6-10.5 MG/DL SID (B)(6), INITIAL RESULT = 14.9 REPEAT RESULT = 5.6. SID (B)(6), INITIAL RESULT = >25.0 REPEAT RESULT = 8.35. SID (B)(6), INITIAL RESULT = 15.9 REPEAT RESULT = 6.2. SID (B)(6), INITIAL RESULT = 22.2 REPEAT RESULT = 8.6 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811166 ↗
• MalfunctionJul 1, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED TOTAL BILIRUBIN RESULTS FOR NUMEROUS PATIENTS ON AN ARCHITECT C4000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 0.2-1.2 MG/DL): INITIAL RESULT, ON (B)(6) 2024, WAS <0.1, REPEAT, ON SAME ANALYZER, WAS <0.1, REPEAT, ON ANOTHER ANALYZER, WAS 0.4 MG/DL. THE CUSTOMER PROVIDED RESULTS FOR ADDITIONAL SAMPLES WITH SAMPLE IDS RANGING FROM 1 TO 28 WITH INITIAL RESULTS RANGING FROM <0.1 TO 0.9 AND REPEAT RESULTS, ON ANOTHER ANALYZER, RANGING FROM 0.2 TO 1.4 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650950 ↗
• MalfunctionJun 3, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR MULTIPLE SAMPLES. THE CUSTOMER OBSERVED INITIAL RESULTS < 0.1 MG/DL, BUT ALL PATIENTS RERAN WERE WITHIN NORMAL RANGE. THE FOLLOWING EXAMPLE RESULTS WERE PROVIDED: (CUSTOMER PROVIDED NORMAL RANGE: 0.2-1.3 MG/DL) INITIAL RESULT: <0.1 MG/DL, REPEAT RESULT 0.2 MG/DL INITIAL RESULT: <0.1 MG/DL, REPEAT RESULT 0.3 MG/DL INITIAL RESULT: <0.1 MG/DL, REPEAT RESULT 0.4 MG/DL INITIAL RESULT: <0.1 MG/DL, REPEAT RESULT 0.4 MG/DL INITIAL RESULT: <0.1 MG/DL, REPEAT RESULT 0.4 MG/DL INITIAL RESULT: <0.1 MG/DL, REPEAT RESULT 0.2 MG/DL INITIAL RESULT : <0.1 MG/DL, REPEAT RESULT 0.4 MG/DL INITIAL RESULT: <0.1 MG/DL, REPEAT RESULT 0.3 MG/DL INITIAL RESULT: <0.1 MG/DL, REPEAT RESULT 0.3 MG/DL INITIAL RESULT : <0.1 MG/DL, REPEAT RESULT 0.2 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446955 ↗
• MalfunctionNov 6, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C16000 FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE <20 UMOL/L): SAMPLE ID (B)(6) INITIAL RESULT = 227 UMOL/L, REPEAT = 9 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 219 UMOL/L, REPEAT = 6 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 59 UMOL/L, REPEAT = 9 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 159 UMOL/L, REPEAT = 18 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 85 UMOL/L, REPEAT = 6 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 84 UMOL/L, REPEAT = 10 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 44 UMOL/L, REPEAT = 4 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 56 UMOL/L, REPEAT = 6 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 62 UMOL/L, REPEAT = 11 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 135 UMOL/L, REPEAT = 19 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 76 UMOL/L, REPEAT = 14 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 84 UMOL/L, REPEAT = 9 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 96 UMOL/L, REPEAT = 10 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 66 UMOL/L, REPEAT = 8 UMOL/L. SAMPLE ID (B)(6) INITIAL RESULT = 74 UMOL/L, REPEAT = 6 UMOL/L. SAMPLE ID (B)(6) INITIAL RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075432 ↗
• MalfunctionOct 11, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C16000 ANALYZER ON TWO PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) = 4.72 MG/DL REPEATED ON ANOTHER ARCHITECT = NORMAL (NO RESULT PROVIDED). SID (B)(6) = 9.38 MG/DL REPEATED ON ANOTHER ARCHITECT = NORMAL (NO RESULT PROVIDED). NORMAL RANGE: 0.2 - 1.2 MG/DLL; NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912737 ↗
• MalfunctionFeb 1, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TOTAL BILIRUBIN RESULTS FOR MULTIPLE SAMPLES WHEN RUNNING ON THE ARCHITECT C8000 PROCESSING MODULE. THE FOLLOWING SIDS WERE PROVIDED BY THE CUSTOMER THAT GENERATED INITIAL RESULTS OF < 0.1 MG/DL SINCE (B)(6)2023. THE QC RUN RIGHT AFTER AND DETERMINED LEVEL 1 WAS OUT OF RANGE LOW AND WAS NOT REPEATED. LEVEL 1 QC ONCE AGAIN WAS OUT OF RANGE LOW ON 16JAN2023. ALL PATIENT SAMPLES WERE RE-TESTED ON ANOTHER ARCHITECT C8000 AND GENERATED RESULTS WITHIN NORMAL RANGE. THE CUSTOMER IMMEDIATELY SENT OUT CORRECTED REPORTS. THE FOLLOWING REPEAT TESTING RESULTS WERE: PATIENT REPEAT RESULTS (UNIT OF MEASURE: MG/DL) (B)(6)= 0.2; (B)(6)= 0.3; (B)(6)= 0.3; (B)(6)= 0.3; (B)(6)= 0.3; (B)(6)= 0.5; (B)(6)= 0.4; (B)(6)= 0.4; (B)(6)= 0.3; (B)(6)= 0.3. THE CUSTOMER¿S NORMAL RANGE FOR TOTAL BILIRUBIN IS 0.2-1.5 MG/DL. THROUGH TROUBLESHOOTING, THE CUSTOMER OPENED FRESH CALIBRATOR, RECALIBRATED THE ASSAY AND RAN QC. THE QC IS NOW ON THE MEAN FOR LEVELS 1, 3, AND THE PEDIATRIC. NO REPEAT TESTING ON THE ANALYZER AFTER TROUBLESHOOTING TASKS WERE PERFORMED WERE PROVIDED BY THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281078 ↗
• MalfunctionJan 10, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS AFTER A NEW WEDGE WAS PUT ON THE INSTRUMENT. THE CUSTOMER NOTICED IT WHEN THEY STARTED TO GET LESS THAN RESULTS ON THEIR PATIENTS. THEY RECALIBRATED THE ASSAY AND RAN QC AND QC CAME WITHIN RANGE; THEY RERAN THEIR PATIENTS AND GOT ACTUAL RESULTS OTHER THAN LESS THAN AND HAD TO MAKE CORRECTED REPORTS. THE FOLLOWING DATA WAS PROVIDED (PATIENT REFERENCE RANGE 0.2 - 1.3 MG/DL): SAMPLE ID ORIGINAL RESULT REPEAT RESULT: (B)(6) 0.19 0.71, (B)(6) 0.1 0.23, (B)(6) 0.1 0.43, (B)(6) 0.65 1.14, (B)(6) 0.1 0.51, (B)(6) 0.1 0.32, (B)(6) 0.1 0.36, (B)(6) 0.1 0.36, (B)(6) 0.1 0.54, (B)(6) 0.1 0.3, (B)(6) 0.55 1.08, (B)(6) 0.1 0.45, (B)(6) 0.31 0.82, (B)(6) 0.1 0.3, (B)(6) 0.1 0.33, (B)(6) 0.24 0.75, (B)(6) 0.1 0.51, (B)(6) 0.12 0.62, (B)(6) 0.1 0.54, (B)(6) 0.1 0.63, (B)(6) 0.57 1.05, (B)(6) 0.1 0.26, (B)(6) 0.1 0.5, (B)(6) 0.1 0.28, (B)(6) 0.14 0.62, (B)(6) 0.33 0.85, (B)(6) 0.7 0.56, (B)(6) 0.5 0.39, (B)(6) 1.2 1.71, (B)(6) 0.4 0.25, (B)(6) 0.18 0.71, (B)(6) 0.34 0.85, (B)(6) 0.6 0.45, (B)(6) 0.5 0.38, (B)(6) 0.7 0.54, (B)(6) 0.1 0.42, (B)(6) 0.3 0.19, (B)(6) 0.1 0.45, (B)(6) 1 1.38, (B)(6) 0.2 0.49, (B)(6) 0.1 0.37, (B)(6) 0.3 0.65,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16133583 ↗
• MalfunctionJun 3, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE SAMPLES FROM NEWBORNS. THE RESULTS ARE 20-25% HIGHER WHEN COMPARED TO OTHER METHODS. THE FOLLOWING EXAMPLE DATA WAS PROVIDED. (B)(6) 2022 SID (B)(6), INITIAL RESULT = 438.8 UMOL/L, REPEAT ON ROCHE = 341.6 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14596862 ↗
• MalfunctionMay 5, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED TOTAL BILIRUBIN RESULTS ON AN ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 3.4-20.5 UMOL/L): INITIAL RESULTS WERE <1.90 AND 1.8, REPEATS AFTER RECALIBRATING WERE 6.7 AND 5.4 UMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291568 ↗
• MalfunctionMar 7, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER ON A PATIENT. RESULTS PROVIDED: (B)(6) 2022 (B)(6) =0.92 MG/DL, ANOTHER ARCHITECT = 1.25 MG/DL (NORMAL RANGE: 0.2-1.20 MG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13681482 ↗
• MalfunctionFeb 28, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED TOTAL BILIRUBIN RESULT GENERATED ON AN ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. SID (B)(6) INITIAL RESULT = 326.8 UMOL/L (RESULT WAS RELEASED FROM LAB). THE PATIENT WAS REDRAWN, SID (B)(6) RESULT = 6 UMOL/L. THE LAB REPEATED THE ORIGINAL SAMPLE, SID (B)(6). THE REPEAT RESULT = 16 UMOL/L. ADDITIONALLY, THE CUSTOMER HAD A QC FLIER DURING THE MORNING. QC RUN: QC L2RANGE 41.770-47.50, RESULT 189.50. ALL OTHER QC LEVELS WERE IN RANGE. THE QC WAS REPEATED AND WAS IN RANGE, 43.60. AS PART OF TROUBLESHOOTING, THE LOGS WERE REVIEWED AND FOUND THREE ASPIRATION THAT WERE INDICATIVE OF BUBBLES, TWO CAUSED EXCEPTIONS AND THE THIRD WAS THE FLIER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13625040 ↗
• MalfunctionJul 28, 2021Low Test Results; Low Test Results

  ADDITIONAL INFORMATION PROVIDED. THE ACCOUNT CONFIRMED THAT THE SAMPLE IS A PEDIATRIC SAMPLE AND VOLUME WAS SHORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239785 ↗
• MalfunctionApr 30, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A FALSELY DEPRESSED ARCHITECT TOTAL BILIRUBIN RESULT. ON (B)(6) 2021 SAMPLE ID (B)(6) GENERATED 16.4 AND REPEAT 117 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11756820 ↗
• MalfunctionApr 20, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A FALSELY DEPRESSED ARCHITECT TOTAL BILIRUBIN RESULT. ON (B)(6) 2021 SAMPLE ID (B)(6) GENERATED 16.4 AND REPEAT 117 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694010 ↗