ARCHITECT 6L45-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380740011383), received between Aug 14, 2017 and Nov 2, 2020 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2020High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED ARCHITECT TOTAL BILIRUBIN RESULT FOR ONE PATIENT. SAMPLE ID (B)(6) GENERATED 8.49 AND REPEAT 0.21 MG/DL. A SERUM SAMPLE FROM THE SAME PATIENT WAS ALSO TESTED, AND GENERATED 0.18 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10771438 ↗
• MalfunctionJul 22, 2020Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED TOTAL BILIRUBIN ON ARCHITECT C8000 PROCESSING MODULE FOR MULTIPLE PATIENTS. ONE EXAMPLE PATIENT RESULT PROVIDED: SID (B)(4) TOTAL BILIRUBIN RESULT=0.20 MG/DL/ REPEATED=0.20 MG/DL/ REPEATED=0.50 MG/DL (NORMAL REFERENCE RANGE=0.2 TO 1.2 MG/DL). THE PERCENT BIAS BETWEEN THE TWO RESULTS ARE 60%. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10309688 ↗
• MalfunctionMay 6, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED ERRATIC TOTAL BILIRUBIN RESULTS ON ONE PATIENT ON THE ARCHITECT C8000 ANALYZER, SERIAL NUMBER (B)(4). THE FOLLOWING DATA WAS PROVIDED: TOTAL BILIRUBIN = 5.4MMOL/L, DIRECT BILIRUBIN = 6.6. THE SAMPLE WAS TESTED ON ANOTHER ARCHITECT C8000, SERIAL NUMBER (B)(4) - TOTAL BILIRUBIN = 6.5MMOL/L, DIRECT BILIRUBIN = 7.0. THE SAMPLE WAS THEN RETESTED ON SN (B)(4) - TOTAL BILIRUBIN = 1.9MMOL/L, DIRECT BILIRUBIN = 5.9. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10028824 ↗
• MalfunctionApr 8, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED ERRATIC TOTAL BILIRUBIN RESULTS ON ONE PATIENT ON THE ARCHITECT C8000 ANALYZER, SERIAL NUMBER (B)(4). THE FOLLOWING DATA WAS PROVIDED: TOTAL BILIRUBIN = 5.4MMOL/L, DIRECT BILIRUBIN = 6.6. THE SAMPLE WAS TESTED ON ANOTHER ARCHITECT C8000, SERIAL NUMBER (B)(4) - TOTAL BILIRUBIN = 6.5MMOL/L, DIRECT BILIRUBIN = 7.0. THE SAMPLE WAS THEN RETESTED ON SN (B)(4) - TOTAL BILIRUBIN = 1.9MMOL/L, DIRECT BILIRUBIN = 5.9. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9939207 ↗
• MalfunctionFeb 25, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS ON APPROXIMATELY 30 PATIENTS GENERATED ON THE ARCHITECT ANALYZER. THE CUSTOMER STATED THE LEVEL I CONTROL FOR TOTAL BILIRUBIN WAS OUT OF RANGE LOW IN THE AFTERNOON. THE MORNING QC HAD BEEN ACCEPTABLE. THE CUSTOMER REPEATED ALL PATIENT SAMPLES FROM THE MORNING. THE RESULTS PROVIDE WERE FOR 12 SAMPLES: ON (B)(6) ORIGINAL = 10.8 /AMENDED =14 (CURRENT ACCEPTANCE RANGE <20UMOL/L); SID (B)(6) = 3.1 /AMENDED= 6; SID (B)(6) =2.4 / AMENDED = 5; SID (B)(6) = 4.4 /AMENDED= 7; SID (B)(6) = 9.9 / AMENDED =14; SID (B)(6) = 5.3 / AMENDED= 8; SID (B)(6) = 3 / RERUN: 5; SID (B)(6) = 13 / RERUN = 16; SID (B)(6) = 7 / RERUN = 10; SID (B)(6) = 12 / RERUN = 15; SID (B)(6) = 7 / RERUN = 9; SID (B)(6) = 9 / RERUN = 12UMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9751255 ↗
• MalfunctionFeb 13, 2020Low Test Results; Low Test Results

  DURING A PATIENT COMPARISON STUDY THE CUSTOMER OBSERVED FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR SEVERAL SAMPLES UPON USE OF CALIBRATOR LOT 05647FD01. THE BIASES OBSERVED WITH THIS CALIBRATOR LOT RANGED FROM 2.9% TO 22.5%. THE CUSTOMER ALSO REPORTED AN OBSERVED NEGATIVE SHIFT IN QC RESULTS DURING THIS TIME. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9707745 ↗
• MalfunctionOct 2, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED MULTIPLE FALSE DECREASED TOTAL BILIRUBIN RESULTS WHEN PROCESSING ON THE ARCHITECT C16000. INITIAL RESULTS RANGED FROM 1.9 TO 38.4 AND RETEST RESULTS RANGED FROM 8 TO 46. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9143743 ↗
• MalfunctionMay 7, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL BILIRUBIN ON ONE PATIENT GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: SID (B)(6) = 107UMOL/L / REPEATED ON DIFFERENT ANALYZER = 8.5 (REFERENCE RANGE = <25UMOL/L). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8587548 ↗
• MalfunctionApr 18, 2019Low Test Results; Low Test Results

  WHILE USING THE CLINICAL CHEMISTRY TOTAL BILIRUBIN ASSAY, THE CUSTOMER INDICATED THAT DECREASED BILIRUBIN RESULTS WERE GENERATED AFTER CALIBRATION WAS COMPLETED WITH A NEW LOT OF CALIBRATOR. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR AN ADULT PATIENT (PROVIDED REFERENCE RANGE 3 - 21 UMOL/L): NOTE: THE RETEST RESULTS WERE GENERATED AFTER CALIBRATION WAS COMPLETED WITH NEW LOT OF CALIBRATOR. THE CUSTOMER INDICATED THE INITIAL RESULTS WERE CONSIDERED CORRECT. SID (B)(6), INITIAL 10.7, AFTER RETEST 7.0, SID (B)(6), INITIAL 5.4, RETEST 3.0, SID (B)(6), INITIAL 9.3, RETEST 4.9, SID (B)(6), INITIAL 7.0, RETEST 3.3, SID (B)(6), INITIAL 7.1, RETEST 4.1, SID (B)(6), INITIAL 10.6, RETEST 5.3, SID (B)(6), INITIAL 13.2, RETEST 9.3, SID (B)(6), INITIAL 17.9 , RETEST 11.4, SID (B)(6), INITIAL 26.6 , RETEST 20.4, SID (B)(6), INITIAL 21.1, RETEST 13.2. THERE HAS BEEN NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8527450 ↗
• MalfunctionApr 2, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS ON TWO PATIENTS GENERATED ON THE ARCHITECT ANALYZER. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL = 152.2 / REPEAT 6.0UMOL/L; SID (B)(6) INITIAL = 110.9 / REPEAT =13.3UMOL//L. THE MEDIC QUESTIONED THE RESULTS PRIOR TO CLINICAL DECISIONS BEING MADE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8475150 ↗
• MalfunctionMar 8, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED TOTAL BILIRUBIN RESULTS ON 44 PATIENTS GENERATED ON THE ARCHITECT ANALYZER. THE CUSTOMER REPORTED A RESULT OF <0.1MG/DL; THEN DURING HER LUNCH ANOTHER TECH HAD 2 MORE RESULT <0.1 AND QUESTIONED THEM. THEY REPLACED THE KIT AND RETESTED THE THREE SAMPLES WITH ALL GENERATING 0.2 (0.3-1.2MG/DL). THE CUSTOMER THEN REPEATED ALL REMAINING 44 SAMPLES FROM (B)(6) 2019 BETWEEN 07:00 TO 13:30, RESULTS RANGED FROM 0.1 TO 1.0. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405229 ↗
• MalfunctionNov 2, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED RESULTS FOR A PEDIATRIC PATIENT WHILE USING CLINICAL CHEMISTRY TOTAL BILIRUBIN REAGENTS WITH THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED. THE CUSTOMER USES NORMAL RANGE LESS THAN OR EQUAL TO 1.9 NG/ML. SID (B)(4), INITIAL 0.7 NG/DL, REPEAT 6.8, 6.8 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8034914 ↗
• MalfunctionOct 10, 2018Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT A FALSELY DECREASED CLINICAL CHEMISTRY TOTAL BILIRUBIN RESULT OF 1.7 MG/DL WAS GENERATED FOR A PEDIATRIC PATIENT SAMPLE TESTED ON THE ARCHITECT C8000 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN ON (B)(6) 2018. THE SAME SAMPLE WAS RETESTED ON (B)(6) 2018 AND THE RESULT WAS 9.6 MG/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953181 ↗
• MalfunctionJul 30, 2018Low Test Results; Low Test Results

  A PHYSICIAN QUESTIONED AN ARCHITECT TOTAL BILIRUBIN RESULT OF 0.5 MG/DL FOR A NEONATAL PATIENT. THE SAMPLE WAS SHORT VOLUME BUT NO ERROR MESSAGE WAS GENERATED. A NEW SAMPLE WAS DRAWN AND THE ARCHITECT TOTAL BILIRUBIN RESULT WAS 11.8 MG/DL. THE CUSTOMER STATED NO ADVERSE IMPACT TO PATIENT MANAGEMENT OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7731270 ↗
• MalfunctionMay 22, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED IMPRECISE AND FALSELY ELEVATED ARCHITECT TOTAL BILIRUBIN RESULTS FOR ONE PATIENT SAMPLE. THE SAMPLE WAS TESTED MULTIPLE TIMES ON MULTIPLE ANALYZERS GENERATING THE FOLLOWING RESULTS: (B)(6). THE CUSTOMER USES A NORMAL RANGE OF LESS THAN 20 UMOL/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7534000 ↗
• MalfunctionApr 5, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED TOTAL BILIRUBIN RESULTS WHILE USING THE CLINICAL CHEMISTRY TOTAL BILIRUBIN REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) INITIAL 1.636 MG/DL, REPEAT 0.509 MG/DL, SID (B)(6) INITIAL 1.807 MG/DL, REPEAT 0.717 MG/DL, SID (B)(6) INITIAL 1.646 MG/DL, REPEAT 0.493 MG/DL, SID (B)(6) INITIAL 1.795 MG/DL, REPEAT 0.674 MG/DL, SID (B)(6) INITIAL 1.582 MG/DL, REPEAT 0.443 MG/DL, SID (B)(6) INITIAL 1.581 MG/DL, REPEAT 0.431 MG/DL, SID (B)(6) INITIAL 2.088 MG/DL, REPEAT 1.045 MG/DL, SID (B)(6) INITIAL 1.711 MG/DL, REPEAT 0.578 MG/DL, SID (B)(6) INITIAL 1.654 MG/DL, REPEAT 0.512 MG/DL, SID (B)(6) INITIAL 1.778 MG/DL, REPEAT 0.66 MG/DL, SID (B)(6) INITIAL 1.835 MG/DL, REPEAT 0.781 MG/DL, SID (B)(6) INITIAL 1.648 MG/DL, REPEAT 0.528 MG/DL, SID (B)(6) INITIAL 1.623 MG/DL, REPEAT 0.453 MG/DL, SID (B)(6) INITIAL 1.605 MG/DL, REPEAT 0.472 MG/DL, SID (B)(6) INITIAL 1.474 MG/DL, REPEAT 0.34 MG/DL, SID (B)(6) INITIAL 1.699 MG/DL, REPEAT 0.592 MG/DL, SID (B)(6) INITIAL 1.548 MG/DL, REPEAT 0.427 MG/DL, SID (B)(6) INITIAL 1.734 MG/DL, REPEAT 0.608 MG/DL, SID (B)(6) INITIAL 1.425 MG/DL, REPEAT 0.278 MG/DL, SID (B)(6) INITIAL 1.756 MG/DL, REPEAT 0.625 MG/

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7400545 ↗
• MalfunctionMar 15, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED TOTAL BILIRUBIN RESULTS WHILE USING THE CLINICAL CHEMISTRY TOTAL BILIRUBIN REAGENTS. THE FOLLOWING DATA WAS PROVIDED. (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7342841 ↗
• MalfunctionAug 14, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED BILIRUBIN RESULTS WHILE USING THE CLINICAL CHEMISTRY TOTAL BILIRUBIN ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING EXAMPLE DATA FROM (B)(6) 2017: PATIENT 1: INITIAL 1.4, RETEST 0.5. PATIENT 2: 2, RETEST 1.1. PATIENT 3: 1.3, RETEST 0.4. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6791660 ↗