ARCHITECT 3M74-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 650 adverse event reports that list this exact device (DI 00380740006235), received between Aug 12, 2016 and Sep 11, 2026 — classified as 17 injuries, 633 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (256 reports).

1 FDA recall record name this device's identifier, 1 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 650 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735101 ↗
• MalfunctionSep 9, 2026False Negative Result

  The customer observed a false negative ARCHITECT Anti-HCV result generated on the ARCHITECT i2000SR Processing Module for an elderly patient that was recently diagnosed with HCV.ARCHITECT result = negative, a positive test strip result, and a positive result when retested result on another ARCHITECT. (no specific results provided). No impact on patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50688451 ↗
• MalfunctionJun 1, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT ON A 4YRS AND 11-MONTH-OLD PATIENT DIAGNOSED WITH ACUTE LYMPHOBLASTIC LEUKEMIA. THE RESULTS PROVIDED WERE: SID (B)(6), INITIAL=0.039 NG/ML /REPEATED=0.002 NG/ML LABORATORY REFERENCE RANGE FOR TROPONIN=< 0.009 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350493 ↗
• MalfunctionApr 30, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE 58-YEAR-OLD MALE PATIENT. THE SAMPLE WAS REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = >64.35 PMOL/L REPEAT = 13.38 PMOL/L. REFERENCE RANGE = 9-19 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25047384 ↗
• MalfunctionApr 6, 2026False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR A 27 YEAR OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6): INITIAL RESULT = 507.08 MIU/ML. (B)(6) 2026, SID UNKNOWN: INITIAL RESULT WAS 1.2 MIU/ML. THE ORIGINAL SAMPLE FROM (B)(6) 2026 WAS REPEATED WHICH GENERATED A RESULT OF 1.2 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796104 ↗
• MalfunctionApr 2, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHTIECT FREE T4 RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A 32-YEAR-OLD FEMALE PATIENT. UPON REPEAT TESTING, THE SAMPLE GENERATED A NORMAL RESULT. THE FOLLOWING DATA WAS PROVIDED: REFERENCE RANGE: 11.0 TO 17.7 PMOL/L SID (B)(6): INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 16.07 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766378 ↗
• MalfunctionMar 31, 2026False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL B-HCG FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE: <5 MIU/ML): INITIAL B-HCG RESULT= 95.19 MIU/ML; REPEAT RESULT= <1.2 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. NO PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747759 ↗
• MalfunctionMar 17, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT ANTI-TPO RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: ON (B)(6) 2026 SID (B)(6): 28YRS OLD FEMALE: INITIAL= > 1000 IU/ML /REPEATED AUTO DILUTION=> 1000 IU/ML; 1:2 MANUAL DILUTION=422.21 IU/ML; REPEATED NEAT=> 1000 IU/ML; 1:2 AUTO DILUTION=629.82 IU/ML. ON (B)(6) 2026 SID (B)(6): 66YRS OLD FEMALE: INITIAL=> 1000 IU/ML; /REPEATED AUTO DILUTION 1:2 =393.42 IU/ML; AFTER 1:20 MANUAL DILUTION= 1060.15 IU/ML. SID (B)(6): 22YRS OLD FEMALE: INITIAL=> 1000 IU/ML; /REPEATED AUTO DILUTION 1:2 = 881.33 IU/ML; AFTER 1:20 MANUAL DILUTION= 1677.43 IU/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618635 ↗
• MalfunctionMar 13, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CA19-9XR RESULT FOR A 66-YEAR-OLD FEMALE DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2026, SID: (B)(6): INITIAL RESULT = 118.59 U/ML, REPEAT = 49.28 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597749 ↗
• MalfunctionMar 11, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I B-HCG RESULTS ON A 20YRS OLD FEMALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2026 INITIAL=208.36 MIU/ML (> 25.0 MIU/ML =POSITIVE) /REPEATED =< 1.2 MIU/ML (< OR =5.0 MIU/ML=NEGATIVE). AT OTHER HOSPITAL HCG=NEGATIVE (NO ACTUAL RESULTS PROVIDED) . THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568129 ↗
• MalfunctionMar 2, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: IT WAS REPORTED THAT A PATIENT RECEIVED TREATMENT DUE TO AN ELEVATED TROPONIN RESULT. THE DETAILS OF THE TREATMENT INCLUDE THAT THERE WAS AN UNSPECIFIED MEDICATION USED. THE CUSTOMER IS NOT AWARE OF ANY HARM THAT OCCURRED TO THE PATIENT. THE CUSTOMER HAD NO INFORMATION REGARDING PATIENT ADMITTING DIAGNOSIS/CHIEF COMPLAINT, PAST MEDICAL HISTORY, AND REPORTED THAT THERE WAS NO INFORMATION PROVIDED IF THE PATIENT WAS EXPERIENCING ANY CARDIAC SYMPTOMS (I.E. CHEST PAIN, ABNORMAL EKG, ETC.). THE CUSTOMER REPORTED THAT THERE WAS NO HISTORY OF ELEVATED TROPONIN OR CARDIAC ISSUES/DIAGNOSES. AGE AND GENDER NOT PROVIDED. LABORATORY INFORMATION: CUSTOMER REFERENCE RANGE IS 3.5-7 NG/L . ON (B)(6)2026: SID (B)(6) RESULT WAS <4. SID (B)(6) RESULT WAS 664. IT WAS REPORTED THAT THE PATIENT RECEIVED TREATMENT. ON (B)(6) 2026: SID: (B)(6) RESULT WAS <4. WHEN REPEATED ON ANOTHER ANALYZER, THE RESULT WAS <4. THE SAMPLE THAT INITIALLY GENERATED THE ELEVATED RESULT (SAMPLE ID (B)(6) WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS <4. THE ELEVATED RESULT WAS CORRECTED TO <4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489995 ↗
• MalfunctionFeb 25, 2026False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT GENERATED ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) (46-YEAR-OLD FEMALE): INITIAL RESULT = 32.41 MIU/ML (THIS RESULT WAS RELEASED AND QUESTIONED BY THE PHYSICIAN). REPEAT RESULT FROM SAME SAMPLE = 0.36 MIU/ML. RETEST FROM A NEW BLOOD DRAW FROM THE PATIENT = 0.00 MIU/ML (REFERENCE RANGE: </= 5.00 MIU/ML). UPON TROUBLESHOOTING, IT WAS FOUND THAT 2 OTHER SAMPLES BEFORE THIS PATIENT SAMPLE GENERATED HIGH-VALUE B-HCG RESULTS WITH > 225000. CARRYOVER FROM THE HIGH-VALUE SAMPLES LED TO THE FALSE POSITIVE B-HCG RESULT FOR THIS SAMPLE IN QUESTION. THE CUSTOMER WAS INSTRUCTED BY ABBOTT CUSTOMER SERVICE TO REPLACE THE SAMPLE PROBE AND CONDUCT A CONTAMINATION TEST ON HIGH-VALUE SAMPLES WAS PERFORMED AND PASSED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447188 ↗
• MalfunctionFeb 11, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL B-HCG RESULTS FOR A 35-YEAR-OLD FEMALE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LAB. THE FOLLOWING DATA WAS PROVIDED:THE INITIAL HCG RESULT FOR SID (B)(6) WAS 595.65 MIU/ML, AND THE RETEST RESULT WAS 1.52 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316227 ↗
• MalfunctionFeb 11, 2026False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT B-HCG RESULT GENERATED ON AN ARCHITECT I2000SR ANALYZER FOR A 28-YEAR-OLD FEMALE PATIENT WHO WAS HAVING A HEALTH EXAMINATION. SID (B)(6) INITIAL RESULT = 540.43 MIU/ML, REPEAT RESULT = <1.2 MIU/ML. THE CUSTOMER REFERENCE RANGE IS 0-5 MIU/ML. THE INSTRUMENT WAS INSPECTED AND TINY CRYSTALS WERE FOUND ON THE SAMPLE PROBE. AFTER CLEANING THE PROBE, THE SAMPLE WAS REPEATED AND GENERATED A RESULT = <1.2 MIU/ML. THE CUSTOMER ISSUED THE RESULT OF <1.2 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314711 ↗
• MalfunctionJan 5, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT STAT TROPONIN-I FOR A 32-YEAR-OLD FEMALE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.04 NG/ML): (B)(6) 2025, SID (B)(6), INITIAL TROPONIN RESULT= 1.38 NG/ML. ANOTHER SAMPLE WAS TESTED WITH A RESULT= 0.021 NG/ML. THE ORIGINAL SAMPLE WAS REPEATED WITH RESULTS= 0.024 NG/ML, 0.014 NG/ML, 0.010 NG/ML, 0.012 NG/ML, 0.010 NG/ML, AND 0.014 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959876 ↗
• MalfunctionDec 19, 2025Patient Data Problem; Patient Data Problem

  THE CUSTOMER REPORTED A SAMPLE BARCODE WAS MISREAD BY THE ARCHITECT I2000SR SID (B)(6) GENERATED BY THE LIS WAS RECOGNIZED AS SID 1 BY THE ANALYZER WHICH OVERRODE THE PREVIOUS RESULTS FOR SID 1. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847736 ↗
• MalfunctionDec 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRATIC ARCHITECT CA 19-9XR RESULTS ON A PATIENT. IT IS UNKNOWN IF THE PATIENT HAS PANCREATIC CANCER. RESULTS PROVIDED: CA 19-9 SID (B)(6): INITIAL TEST 46.16 U/ML, SECOND TEST 61.96 U/ML, THIRD TEST 78.28 U/ML. REFERENCE RANGE 0-37 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23814998 ↗
• MalfunctionDec 8, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE POSITIVE ARCHITECT TOTAL B-HCG RESULT FOR ONE PATIENT SAMPLE GENERATED ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = > 13000 MIU/ML; REPEAT RESULT = < 1.20 MIU/ML COLLOIDAL GOLD METHOD = NEGATIVE. THE CUSTOMER¿S REFERENCE RANGE FOR B-HCG: <5 FOR NON-PREGNANT WOMEN 5-25 FOR EARLY PREGNANCY 1-10 WEEKS FROM LAST MENSTRUAL PERIOD: 202-231000 11-15 WEEKS: 22536-234990 16-22 WEEKS: 8007-50064 23-40 WEEKS: 1600-49413 . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744952 ↗
• MalfunctionDec 4, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE 66-YEAR-OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 22.46 PMOL/L REPEAT = 16.2 PMOL/L FT4: = 19 YEARS 9.0-19.0 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719789 ↗
• MalfunctionNov 11, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED ON THE ARCHITECT I2000SR INSTRUMENT FOR A 57 YEAR OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE WAS <26.2 PG/ML): (B)(6) 2025, SID (B)(6): INITIAL RESULT = 4026.2 PG/ML, REPEAT ON (B)(6) 2025 = 2.7 PG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524213 ↗
• MalfunctionNov 11, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE INITIAL REACTIVE ARCHITECT CMV IGM AND ARCHITECT RUBELLA IGM RESULTS GENERATED ON THE ARCHITECT I2000SR INSTRUMENT. THE CUSTOMER NOTED THAT THE RESULTS WERE REPEATED ON THE SIEMENS (ELECTROCHEMILUMINESCENCE) OR BIOMERIEUX (ELISA) METHODOLOGIES WITH NEGATIVE RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524062 ↗
• MalfunctionNov 11, 2025Smoking; Smoking

  THE CUSTOMER REPORTED SMOKE OBSERVED BEHIND THE ARCHITECT I2000SR¿S FAN AREA. NO USER SAFETY OR IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522723 ↗
• MalfunctionNov 6, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT TOTAL HCG RESULT GENERATED FOR A 28-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE <5 MIU/ML IS NEGATIVE): SAMPLE ID: (B)(6) INITIAL RESULT = 373.87 MIU/ML, REPEAT RESULT = <1.2 MIU/ML. SAME PATIENT, NEW SAMPLE OBTAINED THE NEXT DAY AND RESULT = <1.2 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485231 ↗
• MalfunctionOct 28, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR TWO PATIENT SAMPLES. (> 10 NG/L IS CONSIDERED ABNORMAL, MALE: 4 TO 12 NG/L, FEMALE: 4 TO 10 NG/L THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025 SID (B)(6) 62-YEAR-OLD MALE PATIENT: INITIAL RESULT = 10.2 PG/ML, REPEAT RESULT = <3.2 PG/ML ON (B)(6) 2025 SID (B)(6) 57-YEAR-OLD FEMALE PATIENT: INITIAL RESULT = 11.2 PG/ML, REPEAT RESULT = <3.2 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402236 ↗
• MalfunctionOct 27, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT GENERATED FOR A 32-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE ID (B)(6) INITIAL RESULT = 35.34 PMOL/L, REPEAT = 11.5 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393012 ↗