ARCHITECT 2P24-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 00380740003746), received between Oct 24, 2016 and Sep 30, 2026 — classified as 1 injury, 170 malfunctions.

The most frequently reported specific device problem is “High Test Results” (90 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. Oct 19, 2023Open, Classified

   The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

   Z-0682-2024 · Root cause: Under Investigation by firm · 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 171 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High Test Results

  The customer observed falsely elevated Creatinine results generated on the ARCHITECT c4000 instrument for a. The following data was provided:(Patient normal ranges: Adult Male 0.73-1.18 mg/dL, Adult Female 0.55-1.02 mg/dL)Patient 1(b)(6) 2026, 22-year-old femaleSID (b)(6) initial result 5.87 mg/dL (on (b)(6) repeated 0.73 and 0.69 mg/dL (the patient sample was sent to a sister hospital and repeated on two separate Alinity c analyzers).The patient was sent to emergency room at sister hospital, and a sample was drawn that yielded normal results. The patient did not receive any treatment.Patient 2(b)(6) 2026, 29-year-old femaleSID (b)(6) initial result 2.02 mg/dL (on (b)(6), repeated 0.61 and 0.57 mg/dL (patient sample was sent to a sister hospital and repeated on two separate Alinity c analyzers) No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944582 ↗
• MalfunctionMay 18, 2026High Test Results

  THE CUSTOMER OBSERVED ELEVATED MAGNESIUM WHEN PROCESSING ON THE ARCHITECT C4000 PROCESSING MODULE. A SAMPLE TESTED MAGNESIUM OF 7.2 MG/DL BUT REPEATED 2.0 MG/DL. THE CUSTOMER NORMAL REFERENCE RANGE IS 1.7 ¿ 2.2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204395 ↗
• MalfunctionApr 23, 2026Thermal Decomposition of Device

  THE FIELD SERVICE REPRESENTATIVE (FSR) OBSERVED SMOKE/FIRE ON THE CNN BOARD OF THE ARCHITECT C4000 PROCESSING MODULE DURING AN ONSITE VISIT. THE FSR IDENTIFIED THAT CNN BOARD, CNN 31 CABLE & HCW PUMP (WITH SMELL OF BURNT PARTS) WERE BURNED. THERE WAS NO DAMAGE TO THE CUSTOMER FACILITY. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24964759 ↗
• MalfunctionFeb 17, 2026Device Fell

  THE CUSTOMER REPORTED THAT THE FRONT COVER/DOOR OF THE ARCHITECT C4000 ANALYZER WAS OBSERVED TO FREE FALL WHEN OPENED SLIGHTLY. THE CUSTOMER IDENTIFIED THAT THE COVER DID NOT HOLD ITS POSITION AND COULD DROP UNEXPECTEDLY. THE DOOR WAS SUBSEQUENTLY ADJUSTED TO PREVENT FURTHER FREE FALL. NO INJURY TO THE USER WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370004 ↗
• MalfunctionFeb 16, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE FOR A 84 YEAR OLD MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE 1.8 - 2.7 MG/DL), SID (B)(6) INITIAL RESULT = 6.89 MG/DL, REPEAT RESULT = 1.58 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344766 ↗
• MalfunctionNov 24, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A DISCREPANT GLUCOSE RESULT GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE ON A PATIENT. RESULTS PROVIDED: (B)(6) 2025, SID (B)(6) = 8.75 / 4.49 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633130 ↗
• MalfunctionSep 3, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 1.5 ¿ 2.2 MG/DL): ON (B)(6) 2025, SID (B)(6) (NEWBORN), INITIAL MAGNESIUM RESULT= 5.95 MG/DL; (B)(6) 2025, REPEAT RESULT= 2.10 MG/DL. (B)(6) 2025, SID (B)(6), INITIAL MAGNESIUM RESULT= 8.54 MG/DL; REPEAT RESULT= 1.70 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955968 ↗
• MalfunctionAug 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED INCONSISTENT MAGNESIUM RESULTS WHEN PROCESSING ON THE ARCHITECT C4000 PROCESSING MODULE. SID (B)(6) INITIAL RESULT 3.4 REPEATED ON OTHER ARCHITECT C4000 RESULTED <0.8 MG/DL. SID (B)(6) INITIAL RESULT >8.0 REPEATED ON OTHER ARCHITECT C4000 RESULTED 2.1 AND 2 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22836266 ↗
• MalfunctionAug 7, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE FIELD SERVICE REPRESENTATIVE WAS SWAPPING OUT THE OLD UPS FOR THE NEW UPS AND OBSERVED THE PORT USED TO POWER THE ARCHITECT C4000 PROCESSING MODULE SHOWED SIGNS OF MELTING. THE POWER SPIKE THAT CAUSED THE DAMAGE APPEARED TO HAVE PASSED THROUGH THE ANALYZER AND IT WAS NOTED DAMAGE WAS DONE TO THE SM ACDC BOARD, THE MECH LED BOARD, AND THE LED3 CABLE THAT LINKS THE TWO. NO IMPACT TO PATIENT MANAGEMENT OR IMPACT TO USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736959 ↗
• MalfunctionJul 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6) (MALE PATIENT): INITIAL SODIUM RESULT = 121 MMOL/L, REPEATS = 143 MMOL/L AND 115 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553411 ↗
• MalfunctionJul 2, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 1.6-2.6 MG/DL): INITIAL MAGNESIUM RESULT= 6.74 MG/DL; REPEAT RESULT= 1.7 MG/DL. REPEATED THE SAMPLE 10X AND ALL WERE AROUND 1.7 MG/DL. INITIAL MAGNESIUM RESULT= 2.53 MG/DL; REPEAT RESULT= 1.1 MG/DL; PREVIOUS RESULT FROM ONE HOUR PRIOR WAS 1.1 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383482 ↗
• MalfunctionJun 30, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM AND POTASSIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE CHLORIDE 98-107 MMOL/L; POTASSIUM 3.5 ¿ 5.1 MMOL/L; SODIUM 136 ¿ 145 MOL/L): SID (B)(6), (B)(6) 2025, INITIAL POTASSIUM RESULT= 2.4 MMOL/L; (B)(6) 2025, REPEAT POTASSIUM RESULTS= 3.7 MMOL/L, 3.6 MMOL/L; (B)(6) 2025, INITIAL SODIUM RESULT= 101 MMOL/L; (B)(6) 2025, REPEAT SODIUM RESULTS= 138 MMOL/L, 138 MMOL/L, 138 MMOL/L, 137 MMOL/L, 137 MMOL/L, 137 MMOL/L. UPDATE, ADDITIONAL INFORMATION WAS PROVIDED ON 18JUN2025. SID (B)(6), RESULTS FROM I-STAT: SODIUM= 137 MMOL/L; POTASSIUM= 3.5 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358631 ↗
• MalfunctionJun 23, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED SODIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT THAT WAS NOT RELEASE OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 136 TO 145 MMOL/L): (B)(6) 2025, SID (B)(6), INITIAL SODIUM RESULT= 114 MMOL/L; REPEAT RESULT= 141 MMOL/L; REPEAT RESULT (I-STAT)= 140 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306866 ↗
• MalfunctionMay 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED TOTAL BILIRUBIN RESULTS GENERATED BY THE ARCHITECT C4000 PROCESSING MODULE FOR MULTIPLE PATIENTS. THE SAMPLES WERE REPEATED, AND NORMAL RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL REFERENCE RANGE: 0.2 TO 1.3 MG/DL PATIENT 1: ON (B)(6) 2025, SID (B)(6), INITIAL RESULT = <0.1 MG/DL; REPEAT RESULT = 0.408 MG/DL. PATIENT 2: ON (B)(6) 2025, SID (B)(6), INITIAL RESULT = <0.1 MG/DL; REPEAT RESULT = 0.367 MG/DL. PATIENT 3: ON (B)(6) 2025, SID (NOT PROVIDED) INITIAL RESULT = 0.1 MG/DL: REPEAT RESULT = 0.2 MG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059171 ↗
• MalfunctionApr 15, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE ABBOTT TECHNICAL SUPPORT SPECIALIST (TSS) OBSERVED CHARRING ON THE AC/DC CONTROLLER BOARD ON AN ARCHITECT C4000 ANALYZER. THE TSS WAS ONSITE DUE TO THE CUSTOMER REPORTING INSTRUMENT ERROR MESSAGE, 5373 ¿ AC/DC CONTROLLER BOARD FAILURE, AND NOTICED THE CHARRING ON THE BOARD. IT WAS NOTED THAT THE CAUSE OF THE CHARRING WAS LIQUID FALLING ON THE AC/DC CONTROLLER BOARD. THE BOARD WAS REPLACED, AND THE INSTRUMENT IS WORKING AS EXPECTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21843090 ↗
• MalfunctionMar 20, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED MAGNESIUM GENERATED FROM ARCHITECT C4000 ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING SAMPLE DATA: SAMPLE ID (B)(6): ON (B)(6) 2025 INITIAL RESULT WAS > 8MG/DL. REPEAT 1:5 DILUTION RESULT WAS > 40 MG/DL. REPEAT 1:11 DILUTION RESULT WAS 22.43 MG/DL. WHEN REPEATED ON (B)(6) 2025, THE UNDILUTED RESULT WAS 2.14 MG/DL AND THE 1:10 DILUTION RESULT WAS < 6MG/DL SAMPLE ID (B)(6): ON (B)(6) 2025, THE INITIAL RESULT WAS 6.28 MG/DL AND REPEAT RESULT WAS 1.6 MG/DL. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655028 ↗
• MalfunctionMar 3, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (NORMAL PATIENT RANGE 1.6 ¿ 2.6 MG/DL) INITIAL 7.5 MG/DL, REPEAT RESULT = 1.7 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21504039 ↗
• MalfunctionFeb 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED CALCIUM ON THE ARCHITECT C4000 PROCESSING MODULE FOR TWO PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE: CALCIUM 8.4-10.2 MG/DL): INITIAL CALCIUM RESULT= 3.9 MG/DL; REPEAT RESULT= 8.7 MG/DL. INITIAL CALCIUM RESULT= 3.2 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 21400199 ↗
• MalfunctionFeb 5, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED DISCREPANT CREATININE RESULTS GENERATED ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: THE INITIAL RESULT WAS 9 MG/DL, REPEAT RESULT 1 MG/DL. ADDITIONALLY, THE CUSTOMER PERFORMED PRECISION TESTING FOR TROUBLESHOOTING PURPOSES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312089 ↗
• MalfunctionJan 27, 2025Smoking; Smoking

  THE ABBOTT FIELD SERVICE ENGINEER(FSE) OBSERVED SMOKE AND A SPARK FROM A WIRE CONNECTING THE SMC 1 BOARD AND THE LED BOARD ON THE ARCHITECT C4000, SERIAL NUMBER (B)(6). THE FSE HAD REPLACED THE CPU BOARD AND HAD POWERED UP THE MODULE WHEN THE ISSUE OCCURRED. THE FSE POWERED DOWN AND NOTICED WIRE WAS SANDWICHED BETWEEN SMC BOARD AND THE METAL OF THE NEIGHBORING BOARD CAUSING DAMAGE TO THE WIRE AND SPARKING. NO DAMAGE TO ANY BOARD, WIRE WAS REPLACED AND THE ISSUE RESOLVED NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242953 ↗
• MalfunctionJan 20, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED TOTAL BILIRUBIN ON THE ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL TOTAL BILIRUBIN RESULT <0.1 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 21191794 ↗
• MalfunctionJan 17, 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): ON (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 21178215 ↗
• MalfunctionJan 16, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS GENERATED FROM ARCHITECT C4000 PROCESSING MODULE FOR ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL=118 MEQ/L/REPEATED ON ANOTHER ARCHTIECT =138.0 MEQ/L /REPEATED ON ARCHITECT (B)(6) =138, 135, 138, 138 AND 138 MEQ/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169958 ↗
• MalfunctionDec 11, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE ELEVATED MAGNESIUM GENERATED FROM AN ARCHITECT C4000 ANALYZER AND PROVIDED THE FOLLOWING DATA: NORMAL PATIENT RANGE 1.6 ¿ 2.6 MG/DL. ON (B)(6) 2024, SAMPLE ID (B)(6), INITIAL RESULT WAS 2.31. THE CUSTOMER HAS A RULE TO REPEAT RESULTS > 2. REPEAT RESULT WAS 6.07. REPEAT RESULT ON ANOTHER ANALYZER (SN: (B)(6) WAS 1.9. PER THE CUSTOMER THE DISCREPANT RESULT WAS 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 20905388 ↗
• MalfunctionDec 10, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM FLIER ON AN ARCHITECT C4000 PROCESSING MODULE FOR A PATIENT. RESULTS WERE NOT REPORTED TO THE MEDICAL PROVIDER. THE FOLLOWING PATIENT DATA WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER IS NOT ABLE TO PROVIDE THE SAMPLE ID# NOR THE REFERENCE RANGE. INITIAL MAGNESIUM RESULT = 2.88 MMOL/L, REPEAT FROM ANOTHER ANALYZER= 0.9 MMOL/L, REPEAT ON THIS INSTRUMENT: 0.88, 0.88 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895647 ↗