ARCHITECT 3L77-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 694 adverse event reports that list this exact device (DI 00380740005924), received between Aug 26, 2016 and Sep 29, 2026 — classified as 1 death, 4 injuries, 689 malfunctions.

The most frequently reported specific device problem is “High Test Results” (355 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Sep 29, 2021Open, Classified

   Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.

   Z-0271-2022 · Root cause: Software design · FDA record ↗

2. Sep 29, 2021Open, Classified

   Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.

   Z-0272-2022 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 694 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High Test Results

  The customer reported a falsely elevated potassium result generated on the ARCHITCT c16000 Processing Module for a 71 year old male patient with liver cirrhosis. The following data was provided:SID (b)(6): initial result = 7.29 mmol/L, repeats after re-centrifugation = 4.67 mmol/L and 4.66 mmol/LThe discrepant result was not reported out of the laboratory. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932831 ↗
• MalfunctionSep 23, 2026Low Test Results

  The customer observed falsely depressed Sodium results on the ARCHITECT c16000 Processing Module for one patient. The following results were provided:SID: (b)(6), initial Sodium result= 115.4 mmol/L; repeat result on AU5800 platform= 136 mmol/L; repeat on ARCHITECT after recalibration= 137.6 mmol/L.Reference ranges:Abbott system: 136 - 145 mmol/L,Au5800: 135-145 mmol/L.There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869034 ↗
• MalfunctionSep 9, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697671 ↗
• MalfunctionApr 17, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED POTASSIUM RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR A 66-YEAR-OLD MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE IS 3.5-5.2 MMOL/L). SID (B)(6) INITIAL RESULT = 6.50 MMOL/L, REPEAT RESULT = 4.9 MMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909542 ↗
• MalfunctionApr 3, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ARCHITECT (B)(6) INSTRUMENT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) INITIAL TOTAL BILIRUBIN RESULT WAS 280.84 UMOL/L, REPEATED 71 UMOL/L. THE SAMPLE WAS TESTED ON MINDRAY PLATFORM AND THE RESULT WAS 66.0 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775409 ↗
• MalfunctionMar 31, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CREATININE RESULT FOR ONE PATIENT ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 59-104 UMOL/L): INITIAL RESULT WAS 1437.92, REPEAT RESULT WAS 57.98 UMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746260 ↗
• MalfunctionMar 23, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM (NA) AND CHLORIDE (CL) RESULTS FOR A 39-YEAR-OLD MALE PATIENT ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGES FOR NA ARE 136-145 MMOL/L, AND FOR CL ARE 98-110 MMOL/L): SAMPLE ID (B)(6) INITIAL NA RESULT, ON (B)(6) 2026, WAS 161, REPEAT RESULTS WERE 142 AND 142 MMOL/L; INITIAL CL RESULT WAS 122, REPEAT RESULTS WERE 107 AND 108 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662943 ↗
• MalfunctionJan 21, 2026High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED RESULTS ON MULTIPLE ASSAYS WERE GENERATED BY THE ARCHITECT C16000 PROCESSING MODULE FOR MULTIPLE PATIENTS (ADULTS >12 YEARS OLD). THESE RESULTS WERE RELEASED FROM THE LABORATORY. THE SAMPLES WERE THEN REPEATED ON ANOTHER ANALYZER, AND THE REPEATED RESULTS WERE DETERMINED TO BE CORRECT. THE PATIENTS¿ REPORTS WERE SUBSEQUENTLY AMENDED. THE FOLLOWING DATA WERE PROVIDED: CUSTOMER NORMAL RANGE FOR TOTAL BILIRUBIN: 0.2 TO 1.2 MG/DL ON (B)(6) 2025, SID (B)(6): CARBON DIOXIDE RESULT = 36 MMOL/L, REPEAT RESULT = 24 MMOL/L, TOTAL BILIRUBIN RESULT = 4.4 MG/DL, REPEAT RESULT = 0.3 MG/DL. ON (B)(6) 2025, SID (B)(6): CARBON DIOXIDE RESULT = 32 MMOL/L, REPEAT RESULT = 24 MMOL/L. ON (B)(6) 2025, SID (B)(6): CARBON DIOXIDE RESULT = 35 MMOL/L, REPEAT RESULT = 26 MMOL/L. ON (B)(6) 2025 ,SID (B)(6): CREATININE RESULT = 3.13 MG/DL, REPEAT RESULT = 0.93 MG/DL. ON (B)(6) 2025 ,SID (B)(6): CREATININE RESULT = 3.09 MG/DL, REPEAT RESULT = 1.25 MG/DL. ON (B)(6) 2025, SID (B)(6): CREATININE RESULT = 2.74 MG/DL, REPEAT RESULT = 0.97 MG/DL. ON (B)(6) 2025, SID (B)(6): TOTAL BILIRUBIN RESULT = 0.7 MG/DL, REPEAT RESULT = 0.1 MG/DL . NO IMPACT TO PATIENT MANAGEMENT WAS R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129441 ↗
• MalfunctionJan 6, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULT GENERATED ON A 89 YEARS OLD MALE PATIENT ON THE ARCHITECT C16000. THE FOLLOWING DATA WAS PROVIDED. (B)(6) 2025, SID (B)(6), INITIAL RESULT =3.35 MMOL/L, REPEAT RESULT FROM ANOTHER INSTRUMENT 0.94 MMOL/L. THE CUSTOMER USES REFERENCE RANGE 1.60 ¿ 2.60 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986171 ↗
• MalfunctionDec 10, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED MAGNESIUM RESULTS WHEN PROCESSING ON THE ARCHITECT C16000 PROCESSING MODULE. SID (B)(6) INITIAL RESULT 3.6 (NOT REPORTED OUT OF THE LAB), REPEATED ON ANOTHER ANALYZER OF 0.77, 0.82 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. ADDITIONAL INFORMATION PROVIDED ON 11DEC2025: THE CUSTOMER USES A MAGNESIUM NORMAL RANGE OF 0.66 TO 1.07 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771150 ↗
• MalfunctionDec 2, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED POTASSIUM RESULT GENERATED BY THE ARCHITECT C16000 PROCESSING MODULE FOR AN 80-YEAR-OLD MALE PATIENT DIAGNOSED WITH RESPIRATORY TRACT INFECTION. THE SAMPLE WAS REPEATED, AND THE RESULTS WERE WITHIN THE NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 3.5 TO 5.3 MMOL/L. SID (B)(6): INITIAL POTASSIUM RESULT = 7.79 MMOL/L. REPEAT RESULTS = 4.45 MMOL/L AND 4.22 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693564 ↗
• MalfunctionNov 7, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM (NA) RESULTS GENERATED ON THE ARCHITECT C16000 INSTRUMENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). NA INITIAL RESULT 105 MMOL/L, RERUN 140 AND 141 MMOL/L. SID (B)(6). NA INITIAL RESULT 119 MMOL/L, RERUN 140 AND 141 MMOL/L. SID (B)(6). NA INITIAL RESULT 120 MMOL/L, RERUN 139 AND 139 MMOL/L. SID (B)(6). NA INITIAL RESULT 107 MMOL/L, RERUN 142 AND 142 MMOL/L. NORMAL RANGES IN THIS LAB: NA 136-145 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500456 ↗
• MalfunctionOct 20, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED POTASSIUM RESULT GENERATED BY THE ARCHITECT C16000 PROCESSING MODULE FOR A PATIENT. THE RESULT WAS NOT RELEASED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED, YIELDING A RESULT WITHIN THE NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL REFERENCE RANGE: 3.5 TO 5.7 MMOL/L INITIAL POTASSIUM RESULT = 7.1 MMOL/L REPEAT POTASSIUM RESULT = 5.7 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337013 ↗
• MalfunctionAug 8, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED RESULTS FOR MULTIPLE ASSAYS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: SID: (B)(6): TOTAL BILIRUBIN INITIAL RESULT = 20.593 UMOL/L, REPEAT RESULT = 10.661 UMOL/L. CALCIUM INITIAL RESULT = 3.6752 MMOL/L, REPEAT RESULT = 2.3521 MMOL/L. GLUCOSE INITIAL RESULT = 8.793 MMOL/L (161.6576 MG/DL), REPEAT RESULT = 4.568 MMOL/L (82.2971 MG/DL). POTASSIUM INITIAL RESULT = 8.444 MMOL/L, REPEAT RESULT = 4.3 MMOL/L. SID (B)(6): POTASSIUM INITIAL RESULT = 6.775 MMOL/L, REPEAT RESULT = 3.772 MMOL/L. GLUCOSE INITIAL RESULT = 9.887 MMOL/L (178.1242), REPEAT RESULT = 4.671 MMOL/L (84.1527 MG/DL). SID:(B)(6): POTASSIUM INITIAL RESULT = 7.250 MMOL/L, REPEAT RESULT = 3.933 MMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750087 ↗
• MalfunctionAug 7, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED SODIUM RESULT GENERATED BY THE ARCHITECT C16000 PROCESSING MODULE FOR A PATIENT. THE SAMPLE WAS REPEATED, AND THE RESULT WAS WITHIN THE NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 135 TO 145 MMOL/L. INITIAL SODIUM RESULT = 196 MMOL/L; REPEAT RESULT = 139 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738281 ↗
• MalfunctionAug 4, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS FOR SEVERAL PATIENTS ON AN ARCHITECT C16000 ANALYZER. THE FOLLOWING EXAMPLE WAS PROVIDED (CUSTOMER¿S NORMAL RANGE IS 135-145 MMOL/L): PATIENT 2 INITIAL RESULT WAS 115, REPEAT RESULT, ON ANOTHER ANALYZER, IS 139 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708497 ↗
• MalfunctionJul 16, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED CREATININE RESULT FOR ONE PATIENT SAMPLE WHEN USING THE MULTIGENT ENZYMATIC CREATININE ASSAY ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGES FOR CREATININE: MAN = 64-104 UMOL/L AND FEMALE = 49-90 UMOL/L): INITIAL CREATININE RESULT = 1780 UMOL/L REPEAT CREATININE RESULT = 41 UMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527632 ↗
• MalfunctionJul 8, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CREATINE ENZY RESULTS GENERATED ON THE ARCHITECT C16000 ANALYZER FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: THE INITIAL CREATININE TEST RESULT WAS 212 UMOL/L AND THE RETEST RESULT WAS 68 UMOL/L. REFERENCE RANGE: CRE: 41-73 UMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436699 ↗
• MalfunctionJun 3, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CALCIUM RESULT GENERATED BY THE ARCHITECT C16000 PROCESSING MODULE FOR A PATIENT. THE SAMPLE WAS REPEATED ON ANOTHER INSTRUMENT AND A NORMAL RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 8.6 TO 10.6 MG/DL. INITIAL RESULT = 17.9 MG/DL; REPEAT RESULT = 9.2 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22130455 ↗
• MalfunctionMay 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C16000 PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 0.61-1.03 MMOL/L): INITIAL RESULT = 1.02 MMOL/L; REPEAT RESULT = 0.52 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080625 ↗
• MalfunctionMay 23, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS ON THE ARCHITECT C16000 PROCESSING MODULE FOR ONE PATIENT. THE SAMPLE WAS REPEATED WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 99.5 MMOL/L. REPEAT RESULT = 138.36 MMOL/L. REFERENCE RANGE = 137-147 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078658 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER STATED THAT SHE PUNCTURED HER THUMB WITH A METAL NOZZLE WHILE REPLACING THE DRY TIP DURING MONTHLY MAINTENANCE ON THE ARCHITECT C16000 PROCESSING MODULE. SHE WAS WEARING GLOVES AT THE TIME OF THE INCIDENT. THE CUSTOMER CONFIRMED THAT THE PUNCTURE WAS BLEEDING; HOWEVER, THE AREA WAS CLEANED WITH WATER. THE CUSTOMER WENT TO THE EMERGENCY ROOM, WHERE SHE RECEIVED A TETANUS SHOT. BLOOD WAS ALSO DRAWN FOR HEPATITIS B TESTING. THE CUSTOMER IS DOING OK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22071362 ↗
• MalfunctionMay 13, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER OBSERVED AN ERROR CODE 5168 CUVETTE TAB NOT DETECTED ON THE ARCHITECT C16000 PROCESSING MODULE. UPON INSPECTION THE DAQ BOARD NS WAS BURNT. UPDATE, ADDITIONAL INFORMATION WAS PROVIDED ON 01MAY2025. THE CUSTOMER WAS CONNECTING THE PRESSURIZED PURIFIED WATER TO THE BACK OF THE INSTRUMENT AND FORGOT TO TURN OFF THE WATER RECEIVER SWITCH. AFTER THE WATER TANK WAS FULL THE WATER SPRAYED TOWARDS THE CEILING AND DRIPPED ONTO THE ANALYZER. THE CUSTOMER SHUT OFF THE ANALYZER AND CLEANED UP THE WATER. THE ANALYZER WOULD NOT TURN BACK ON. UPON INSPECTION, THERE WERE LEADS OF THE ELECTRONIC COMPONENTS ON THE DAQ BOARD THAT HAD SHORTED OUT AND MELTED AND SIGNS OF SHORTING AND BURNING OUT ON THE DAQ BOARD. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THERE WAS NO HARM TO THE USER REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010441 ↗
• MalfunctionMay 7, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED POTASSIUM RESULTS GENERATED FROM ARCHITECT C16000 PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: PATIENT 1: SID (B)(6) INITIAL=7.08 MMOL/L /REPEATED ON BLOOD GAS ANALYZER=4.7 MMOL/L. PATIENT 2: SID (B)(6) INITIAL=6.6 MMOL/L /REPEATED ON ARCHITECT (B)(6) =3.5 MMOL/L /REPEATED ON BLOOD GAS ANALYZER=3.6 MMOL/L. LABORATORY REFERENCE RANGE FOR POTASSIUM=3.5 TO 5.2 MMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977980 ↗
• MalfunctionMay 6, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED POTASSIUM RESULT GENERATED BY THE ARCHITECT C16000 PROCESSING MODULE FOR A PATIENT. THE SAMPLE WAS REPEATED, AND A LOWER RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE: 3.5 TO 5.0 MMOL/L. SID (B)(6) INITIAL RESULT = 9.1 MMOL/L; REPEAT RESULT = 4.9 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966935 ↗