ARCHITECT 6L45-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380740174965), received between Sep 17, 2020 and Dec 22, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “High Test Results” (18 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED BILIRUBIN GENERATED FROM ARCHITECT ANALYZER. AFTER RECALIBRATION, RETESTING GENERATED NORMAL RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING DATA: CUSTOMER NORMAL RANGE: 3.4-20.5 MOL/L. SAMPLE ID (B)(6) INITIAL RESULT WAS 2.7 AND REPEAT RESULT WAS 4.1. SAMPLE ID (B)(6) INITIAL RESULT WAS 2.4 AND REPEAT RESULT WAS 3.8. SAMPLE ID (B)(6) INITIAL RESULT WAS 2.4 AND REPEAT RESULT WAS 3.7. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866607 ↗
• MalfunctionMar 13, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT WHEN COMPARED TO OTHER REFERENCE LABS USING A DIFFERENT METHOD. THE CUSTOMER OBSERVED THE RESULTS FROM THE ARCHITECT ARE HIGH WHILE THE RESULTS FROM THE REFERENCE LABS (B)(6) AND (B)(6) ARE IN THE NORMAL RANGE OF 0.2-1.2 MG/DL. THE CUSTOMER STATES THE DOCTOR DECLINED TO PROVIDE RESULTS FROM THE REFERENCE LABS. THE CUSTOMER REVIEWED THE PATIENT RESULTS FROM THEIR FACILITY WITH RESULTS GOING BACK TO 2017 RANGING FROM 1.3-2.6 MG/DL. CUSTOMER STATES THEY HAVE NO ISSUES WITH CAP FAILURES, CALIBRATIONS, OR QUALITY CONTROL ISSUES. AN EXAMPLE WAS PROVIDED FROM 2017 ARCHITECT SID (B)(6), RESULT = 1.5 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599429 ↗
• MalfunctionMar 13, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT WHEN COMPARED TO OTHER REFERENCE LABS USING A DIFFERENT METHOD. THE CUSTOMER OBSERVED THE RESULTS FROM THE ARCHITECT ARE HIGH WHILE THE RESULTS FROM THE REFERENCE LABS ((B)(6)) ARE IN THE NORMAL RANGE OF 0.2-1.2 MG/DL. THE CUSTOMER STATES THE DOCTOR DECLINED TO PROVIDE RESULTS FROM THE REFERENCE LABS. THE CUSTOMER REVIEWED THE PATIENT RESULTS FROM THEIR FACILITY WITH RESULTS GOING BACK TO 2017 RANGING FROM 1.3-2.6 MG/DL. CUSTOMER STATES THEY HAVE NO ISSUES WITH CAP FAILURES, CALIBRATIONS, OR QUALITY CONTROL ISSUES. AN EXAMPLE WAS PROVIDED FROM 2022 ARCHITECT (SN (B)(6)) RESULTS = 2.3 MG/DL ADDITIONALLY, THE FOLLOWING PATIENT TOTAL BILIRUBIN RESULTS FROM (B)(6) AT THE (B)(6) HOSPITAL (UNKNOWN WHICH ARE ARCHITECT OR ALINITY): (B)(6) 2023, SID (B)(6), RESULT = 2.3 MG/DL. (B)(6) 2023, SID (B)(6), RESULT = 1.8 MG/DL. (B)(6) 2023, SID (B)(6), RESULT = 1.9 MG/DL. (B)(6) 2022, SID (B)(6), RESULT = 1.7 MG/DL. (B)(6) 2022, SID (B)(6), RESULT = 1.7 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595441 ↗
• MalfunctionFeb 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID: (B)(6) TOTAL BILIRUBIN RESULT WAS <1.8 UMOL/L, REPEAT ON AN ALINITY AT ANOTHER LABORATORY = 5.8 UMOL/L AND 7.7 UMOL/L. ADDITIONAL LABORATORY RESULTS WERE PROVIDED: DIRECT BILIRUBIN RESULT = 35 UMOL/L, REPEAT ON AN ALINITY AT ANOTHER LABORATORY = 25.8 UMOL/L AND 33.5 UMOL/L. IGM RESULTS = 101.6 AND 97.7. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395105 ↗
• MalfunctionJan 9, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED TOTAL BILIRUBIN ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE, TOTAL BILIRUBIN, 0.20 TO 1.20 MG/DL): (B)(6) 2024, SID (B)(6) , INITIAL TOTAL BILIRUBIN RESULT= 26.36 MG/DL; REPEAT RESULT= 0.37 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114760 ↗
• MalfunctionNov 20, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE CUSTOMER REPLACED THE REAGENT, PERFORMED CALIBRATION, AND REPEATED THE SAMPLE WHICH GENERATED A NORMAL RESULT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE: 0.2 TO 1.2 MG/DL PATIENT 1: INITIAL RESULT: 1.26 MG/DL, REPEAT RESULT = 0.5 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737949 ↗
• MalfunctionMay 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL BILIRUBIN ON THE ARCHITECT C4000 PROCESSING MODULE FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) (B)(6) 2024 INITIAL TOTAL BILIRUBIN RESULT= 2.15 MG/DL; (B)(6) 2024 REPEAT RESULTS= 0.85 AND 0.84 MG/DL SID (B)(6) (B)(6) 2024 INITIAL TOTAL BILIRUBIN RESULT= 2.09 MG/DL; (B)(6) 2024 REPEAT RESULTS= 0.56 AND 0.56 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341838 ↗
• MalfunctionApr 1, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR A PATIENT. THE SAME SAMPLE WAS TESTED ON THE ROCHE PLATFORM AND A LOWER RESULT WAS OBTAINED. AS PART OF TROUBLESHOOTING, THE ASSAY WAS RECALIBRATED AND THE SAME SAMPLE GENERATED A NORMAL RESULT POST RECALIBRATION. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE: 0.2 TO 1.20 MG/DL. INITIAL RESULT = 1.97 MG/DL. REPEAT RESULT POST RECALIBRATION = 1.08 MG/DL. ROCHE PLATFORM RESULT = 1.01 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016608 ↗
• MalfunctionMar 18, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS FOR 14 PATIENT SAMPLES WHILE RUNNING ON THE ARCHITECT C4000 PROCESSING MODULE. THE CUSTOMER STATED THERE WERE 50 TESTS LEFT IN THE TOTAL BILIRUBIN REAGENT KIT AND THE SAMPLES GAVE RESULTS OF 0.10 MG/DL. THE CUSTOMER REPORTS OUT LINEARITY FOR THIS ASSAY AS AN ACTUAL RESULT. THE CUSTOMER NOTICED THE TREND ON THE VALUES BEING GENERATED AND MOVED THE TESTING TO A SECOND REAGENT KIT ALREADY LOADED ON BOARD. THE KIT THAT WAS IN USE THAT GENERATED THE DISCREPANT RESULTS WAS DISCARDED BY THE CUSTOMER. ALL 14 SAMPLES WHEN TESTED WITH THE NEW TOTAL BILIRUBIN REAGENT KIT GAVE AN ACTUAL VALUE WHEN REPEATED. THE CUSTOMER ISSUED 14 AMENDED REPORTS TO THE PROVIDERS. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE: 0.2-1.2 MG/DL - UNIT OF MEASURE: MG/DL) SAMPLE 1: INITIAL RESULT = < 0.10 / REPEAT RESULT = 0.31, SAMPLE 2: INITIAL RESULT = < 0.10 / REPEAT RESULT = 0.37, SAMPLE 3: INITIAL RESULT = < 0.10 / REPEAT RESULT = 0.29, SAMPLE 4: INITIAL RESULT = < 0.10 / REPEAT RESULT = 0.45, SAMPLE 5: INITIAL RESULT = < 0.10 / REPEAT RESULT = 0.35, SAMPLE 6: INITIAL RESULT = < 0.10 / REPEAT RESULT = 0.44, SAMPLE 7: INITIAL RESULT = < 0.10 / REPEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924824 ↗
• MalfunctionJan 12, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY INCREASED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER FOR ONE PATIENT. THE CUSTOMER REPEATED THE SAMPLE WHICH GENERATED A LOWER RESULT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 414.7 UMOL/L, REPEAT RESULT = 213.8 UMOL/L. CUSTOMER¿S REFERENCE RANGE = 3.3-254.9 UMOL/L. OTHER RESULTS PROVIDED: DIRECT BILIRUBIN = 6.7 AND 7.6 UMOL/L. ICTERUS = 287.4(3+) 296.5(3+). HEMOLYSIS = 8.39(4+) AND 8.21(4+). LIPEMIA = 0.86(1+) AND 0.94(1+) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503709 ↗
• MalfunctionOct 9, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED QUALITY CONTROL VALUES SHIFTED DOWNWARD BUT STILL WITHIN RANGE WHEN USING THE CC BILIRUBIN ASSAY ON THE ARCHITECT C4000 PROCESSING MODULE. THE CUSTOMER STATED THEY ARE REPEATING PATIENT SAMPLES THAT GENERATED A FALSELY DECREASED RESULT OF < 0.1 MG/DL AND THE CUSTOMER HAS BEEN SEEING A CHANGE IN REPEAT PATIENT RESULTS. THE CUSTOMER WAS RERUNNING THE SAMPLES ON THE SAME ANALYZER USING FRESH REAGENT AND QUALITY CONTROL. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) : PREVIOUS RESULT = < 0.1 MG/DL; REPEAT RESULT = 0.2 MG/DL. SAMPLE ID (B)(6) : PREVIOUS RESULT = < 0.1 MG/DL; REPEAT RESULT = 0.3 MG/DL. SAMPLE ID (B)(6) : PREVIOUS RESULT = <0.1 MG/DL; REPEAT RESULT = 0.2 MG/DL. SAMPLE ID (B)(6) : PREVIOUS RESULT = < 0.1 MG/DL; REPEAT RESULT = 0.2 MG/DL. SAMPLE ID (B)(6) : PREVIOUS RESULT = < 0.1 MG/DL; REPEAT RESULT = 0.2 MG/DL. SAMPLE ID (B)(6) : PREVIOUS RESULT = < 0.1 MG/DL; REPEAT RESULT = 0.1 MG/DL. SAMPLE ID (B)(6) : PREVIOUS RESULT = < 0.1 MG/DL; REPEAT RESULT = 0.1 MG/DL. SAMPLE ID (B)(6) : PREVIOUS RESULT = < 0.1 MG/DL REPEAT RESULT = 0.2 MG/DL. SAMPLE ID (B)(6) : PREVIOUS RESULT = < 0.1 MG/DL; REPEAT RESULT = 0.1 MG/DL. SAMPLE ID (B)(6) : PREVIOUS RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901071 ↗
• MalfunctionAug 30, 2023Low Test Results; Low Test Results

  THE CUSTOMER INITIALLY REPORTED PROBLEMS WITH THE TOTAL BILIRUBIN QC ON AN ARCHITECT ANALYZER AND THEN FURTHER REPORTED THAT THEY HAD ISSUES WITH RESULT FOR A PEDIATRIC PATIENT WHEN CHANGING TO A NEW REAGENT LOT AND PROVIDED THE FOLLOWING DATA: CUSTOMER NORMAL RANGE FOR TOTAL BILIRUBIN WAS 0.2 TO 1.2 MG/ML AND FOR DIRECT BILIRUBIN WAS 0.1 TO 0.3 MG/ML. THE INITIAL RESULT GENERATED FROM THE NEW LOT WAS 16. THE SAMPLE WAS REPEATED AFTER THE ASSAY WAS RECALIBRATED WITH A NEW CALIBRATOR AND GENERATED A RESULT OF 11. THE CUSTOMER REPORTED THAT THE ANALYZER THAT WAS ROUTINELY USED GENERATED A TOTAL BILI OF 12 AND DIRECT BILI OF 0.4 AND THE EMERGENT ANALYZER GENERATED A TOTAL BILI OF 9.07 AND DIRECT BILI OF 0.32. IT WAS FURTHER REPORTED THAT DURING A PERFORMANCE TEST THE CALIBRATOR REQUIRED TO BE RECONFIGURED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650647 ↗
• MalfunctionAug 16, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT TOTAL BILIRUBIN AND WHEN REPEATED WITH ANOTHER BOTTLE OF REAGENT THE RESULTS WERE NORMAL. THE CUSTOMER PROVIDED THE FOLLOWING DATA: (CUSTOMER¿S REFERENCE RANGE WAS 3.4-20.5UMOL/L). SAMPLE 1 INITIAL RESULT WAS 26.21, REPEAT RESULT WAS 10.26. SAMPLE 2 INITIAL RESULT WAS 22.19, REPEAT RESULT WAS 5.73. SAMPLE 3 INITIAL RESULT WAS 28.71, REPEAT RESULT WAS 5.44. SAMPLE 4 INITIAL RESULT WAS 27.12, REPEAT RESULT WAS 11. SAMPLE 5 INITIAL RESULT WAS 56, REPEAT RESULT WAS 37.8. PER THE CUSTOMER, THE RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557468 ↗
• MalfunctionAug 15, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C8000 PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING EXAMPLE RESULTS WERE PROVIDED: 24JUL2023 SID (B)(6)INITIAL RESULT = < 1.7 UMOL/L, REPEAT RESULT = 2.54 UMOL/L ADDITIONALLY, THE FOLLOWING PRECISION TEST WAS PERFORMED WITH THE FOLLOWING RESULTS: 5.69 UMOL/L, 5.43 UMOL/L, 5.43 UMOL/L, 5.26 UMOL/L, 5.21 UMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548298 ↗
• MalfunctionJul 31, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C4000 ANALYZER FOR ONE PEDIATRIC PATIENT. A NEW SAMPLE WAS COLLECTED AND RAN AND THE RESULT WAS HIGHER. THE CUSTOMER REPEATED THE ORIGINAL SAMPLE WITH A HIGHER RESULT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 0.5 REPEAT RESULT ON SAME SAMPLE = 6.3 NEW SAMPLE SID (B)(6) = 6.3 NORMAL RANGE FOR PEDIATRIC = 0.2-8.0 MG/DL EARLIER RESULT FROM (B)(6) 2023 = 8.9 MG/DL UPDATED INFORMATION PROVIDED (B)(6) 2023 = CUSTOMER STATES SID WHEN SCANNED ON THE INSTRUMENT IS SHORTER BUT LAST 8 ALPHANUMERIC NUMBERS ARE THE SAME. SID ON INSTRUMENT ¿(B)(6)¿ REPEAT RESULT ON SAME SAMPLE WAS 6.37 AND ON NEW SAMPLE WAS 6.32 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17425240 ↗
• MalfunctionJul 13, 2023High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT TOTAL BILIRUBIN RESULT OF 14.5 MG/DL WAS GENERATED. SID (B)(6) JUNE 24, 2023 PATIENT AGE: 34 HOURS INITIAL RESULT: 14.5 MG/DL AT 4:42 A.M. NORMAL RANGE: 0.1 - 10.3 MG/DL THE PATIENT WAS PUT UNDER A PHOTO BLANKET FOR 2 HOURS. A NEW SAMPLE FROM THE PATIENT WAS TESTED AT 6:02 P.M. GENERATING A RESULT OF 4.3 MG/DL. THE INITIAL SAMPLE WAS THEN RETESTED. SAME C8000 ANALYZER (SERIAL NUMBER (B)(6)) RESULT OF 6.1 MG/DL. DIFFERENT C8000 ANALYZER (SERIAL NUMBER (B)(6)) RESULT OF 5.9 MG/DL THE REDRAWN SAMPLE WAS RETESTED. SAME C8000 ANALYZER (SERIAL NUMBER (B)(6)) RESULT OF 4.5 MG/DL. DIFFERENT C8000 ANALYZER (SERIAL NUMBER (B)(6)) RESULT OF 4.3 MG/DL THE CUSTOMER STATED THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17318272 ↗
• MalfunctionJul 6, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS FOR A NEWBORN PATIENT (30 HOURS OLD) WHO WAS TREATED WITH A PHOTO BLANKET FOR 10 HOURS. ON (B)(6) 2023 FOR SID (B)(6) THE INITIAL RESULT WAS 19.7 MG/DL (SAMPLE INTEGRITY +1 HEMOLYSIS), THE NEWBORN WAS PLACED UNDER THE PHOTO BLANKET. A NEW SAMPLE WAS RECOLLECTED A COUPLE OF HOURS LATER AND THE RESULT WAS 6.3 MG/DL (NORMAL RANGE 0.1 ¿ 10.3 MG/DL). THE ISSUE WAS DISCOVERED ON (B)(6) 2023 BUT THE SAMPLE WAS ALREADY DISCARDED; UNABLE TO RERUN TESTS. THE NEWBORN RECEIVED TREATMENT WITH A PHOTO BLANKET FOR 10 HOURS. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17267587 ↗
• MalfunctionJul 1, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULT GENERATED ON THE ARCHITECT C8000 ANALYZER FOR ONE PATIENT. THE SAMPLE INITIALLY GENERATED AN ABSORBANCE ERROR. THE CUSTOMER DILUTED THE SAMPLE, AND THE RESULT WAS REPORTED OUT OF THE LAB. THE SAME SAMPLE WAS REPEATED, AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2023 SID (B)(6) INITIAL RUN = ABSORBANCE ERROR. DILUTED RESULT (1:10 DILUTION) = < 2.0 MG/DL. ON (B)(6) 2023 SAME SAMPLE REPEATED RESULT (UNDILUTED) = 0.63. CUSTOMER¿S NORMAL REFERENCE RANGE = 0.2 TO 1.2 MG/DL. THE CUSTOMER CORRECTED THE REPORT FROM < 2.0 MG/DL TO 0.63 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17244181 ↗
• MalfunctionJun 19, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN ON ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL=4.59 MG/DL /REPEATED AFTER CALIBRATION AND CORRECTED THE RESULTS=0.77 MG/DL LABORATORY REFERENCE RANGE FOR TOTAL BILIRUBIN= 0.2 TO 1.2 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153415 ↗
• MalfunctionMar 27, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS ON ARCHITECT C8000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL=174.5 UMOL/L AND 177.3 UMOL/L /REPEATED=NORMAL (NO ACTUAL RESULTS PROVIDED) LABORATORY REFERENCE RANGE FOR TOTAL BILIRUBIN=3.4 TO 20.5 UMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619282 ↗
• MalfunctionFeb 16, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C4000 ANALYZER FOR THREE PATIENTS AFTER SWITCHING TO A NEW LOT OF BILIRUBIN CALIBRATOR. THE CUSTOMER ALSO NOTED A DOWNWARD SHIFT ON QUALITY CONTROLS AND ONE OF THE THREE CONTROL LEVELS WERE OUT OF RANGE. THE CUSTOMER BELIEVED THE RESULTS FROM THE OLD CALIBRATOR WERE CORRECT. THE FOLLOWING DATA WAS PROVIDED: TOTAL BILIRUBIN NORMAL PATIENT RANGES: 3.4 TO 20.5 UMOL/L. SID (B)(6): RESULT (NEW CALIBRATOR) = 17.4 UMOL/L; RESULT (OLD CALIBRATOR) = 23.9 UMOL/L. SID (B)(6): RESULT (NEW CALIBRATOR) = 18.9 UMOL/L; RESULT (OLD CALIBRATOR) = 24.8 UMOL/L. SID (B)(6): RESULT (NEW CALIBRATOR) = 18.6 UMOL/L; RESULT (OLD CALIBRATOR) = 27.3 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384927 ↗
• MalfunctionDec 13, 2022High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT TOTAL BILIRUBIN RESULTS ON 4 SAMPLES THAT REPEATED LOWER WHEN PROCESSING ON THE ARCHITECT C16000. THE ACCOUNT USES A REFERENCE RANGE OF 3.4 TO 20.5 UMOL/L. SID (B)(6) (FEMALE, 32 YEAR OLD, HAN/CHINESE) TESTED 1.7 REPEATED 7.2 UMOL/L. SID (B)(6) (FEMALE, 29 YEAR OLD, HAN/CHINESE) TESTED 1.40 REPEATED 12.4 UMOL/L. SID (B)(6) (FEMALE, 28 YEAR OLD, HAN/CHINESE) TESTED 3.1 REPEATED 8.1 UMOL/L. SID (B)(6) (FEMALE, 29 YEAR OLD, HAN/CHINESE) TESTED 0.8 REPEATED 7.2 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973138 ↗
• MalfunctionDec 8, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED A PHYSICIAN IS QUESTIONING ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C8000 ANALYZER ON TWO PATIENTS. RESULTS PROVIDED: (UOM MG/DL) NEWBORN FEMALE. (B)(6) 2022 SID (B)(6) = 7.4, REF RANGE [0.0-10.0], (B)(6) 2022 SID (B)(6) = 17.8, REF RANGE [0.0-17.4], (B)(6) 2022 SID (B)(6) = 16.8, REF RANGE [0.0-17.4], (B)(6) 2022 SID (B)(6) RESULTS ARE 13.5, REF RANGE [0.0-13.2], (B)(6) 2022 (B)(6) RESULTS ARE 11.4, REF RANGE [0.0-7.3]. NEWBORN MALE (B)(6) 2022 SID (B)(6) = 8.7, REF RANGE [0.0-10.0], (B)(6) 2022 SID (B)(6) = 19.3, REF RANGE [0.0-17.4], (B)(6) 2022 SID (B)(6) = 19.5, REF RANGE [0.0-17.4], (B)(6) 2022 SID (B)(6) = 14.1, REF RANGE [0.0-17.4], (B)(6) 2022 SID (B)(6) = 12.5, REF RANGE [0.0-17.4], (B)(6) 2022 SID (B)(6) = 12.0, REF RANGE [0.0-17.4], (B)(6) 2022 SID (B)(6) = 18.8, REF RANGE [0.0-7.3]. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939461 ↗
• MalfunctionAug 18, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C8000 ANALYZER FOR MULTIPLE PATIENT SAMPLES. THE CUSTOMER REPEATED THE SAMPLES ON ANOTHER INSTRUMENT WHICH GENERATED HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: NORMAL RANGE IS 0.3 TO 1.2 MG/DL PATIENT A INITIAL RESULT = < 0.1 MG/DL, REPEAT RESULT (C803623) = 0.2 MG/DL, PREVIOUS RESULT (5 DAYS PRIOR) = 0.9 MG/DL. PATIENT B INITIAL RESULT = < 0.1 MG/DL, REPEAT RESULT (C803623) = 0.2 MG/DL, NO PREVIOUS RESULT PATIENT 1 INITIAL RESULT =0.6 MG/DL, REPEAT RESULT (C803623) = 0.8 MG/DL PATIENT 2 INITIAL RESULT = 0.5 MG/DL, REPEAT RESULT (C803623) = 0.7 MG/DL PATIENT 3 INITIAL RESULT = <0.1 MG/DL, REPEAT RESULT (C803623) = 0.2 MG/DL PATIENT 4 INITIAL RESULT = 0.2 MG/DL, REPEAT RESULT (C803623) = 0.4 MG/DL PATIENT 5 INITIAL RESULT = 0.1 MG/DL, REPEAT RESULT (C803623) = 0.3 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15256281 ↗
• MalfunctionJul 25, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TOTAL BILIRUBIN RESULTS AFTER INSTALLING A NEW REAGENT CARTRIDGE (SAME LOT NUMBER BUT NEW CARTRIDGE) ON (B)(6) 2022. THE CUSTOMER USES A NORMAL RANGE OF 0.2 - 1.2 MG/DL. THE CUSTOMER STATED THEY RECALIBRATED THE ASSAY USING THE SAME REAGENT CARTRIDGE, THEN REPEATED ALL THE PATIENT SAMPLES WHICH RECOVERED HIGHER. THE CUSTOMER PROVIDED 4 EXAMPLES. INITIAL LOW RESULTS WERE REPORTED TO THE PHYSICIAN. SID (B)(6): 0.23 MG/DL, RETESTED AT 1.01 MG/DL. SID (B)(6): 0.64 MG/DL, RETESTED AT 1.43 MG/DL. SID (B)(6): 0.39 MG/DL, RETESTED AT 1.23 MG/DL. SID (B)(6): 0.44 MG/DL, RETESTED AT 1.23 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094003 ↗