ARCHITECT 03M7484Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380740107222), received between Dec 27, 2018 and Feb 23, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A 49-YEAR-OLD MALE PATIENT. THE PATIENT WAS DIAGNOSED WITH DIFFICULTY SWALLOWING, SHORTNESS OF BREATH, CHEST PAIN, AND NON-ST-SEGMENT ELEVATED MYOCARDIAL INFARCTION (NSTEMI). THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE PATIENT WAS GIVEN AN ASPIRIN 324 MG, ROSUVASTATIN, ESOMEPRAZOLE, CELECOXIB, PA (POSTEROANTERIOR) AND LATERAL CHEST X-RAY, ELECTROCARDIOGRAM EKG (NORMAL), AND A CT (COMPUTED TOMOGRAPHY) SCAN OF THE CHEST WITH CONTRAST. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED NORMAL REFERENCE RANGE 0-35 PG/ML) ON (B)(6) 2026 SID (B)(6) INITIAL 103.5 PG/ML, REPEAT RESULT ON BOTH INSTRUMENTS = <3.5 PG/ML THE CUSTOMER REPORTED THEY BELIEVE THE CORRECT RESULT IS <3.5 PG/ML. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412745 ↗
• MalfunctionJan 28, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I FOR ONE PATIENT. THE PATIENT SAMPLE WAS REPEATED ON THE SAME INSTRUMENT WITH LOWER RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: REFERENCE RANGES: FEMALES <17 NG/L, MALES <35 NG/L. ON (B)(6) 2026, SID (B)(6), 85-YEAR-OLD FEMALE, INITIAL TROPONIN RESULT= 24 NG/L; REPEAT RESULT= <3.5 NG/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202660 ↗
• MalfunctionDec 10, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED TROPONIN-I STAT HIGH SENSITIVITY RESULTS FOR A 74-YEAR-OLD MALE PATIENT THAT IS CURRENTLY STILL HOSPITALIZED IN THE INTENSIVE CARE UNIT (ICU). (LAB CUTOFF IS >35 NG/L IS CRITICAL) THE FOLLOWING RESULTS WERE PROVIDED: INITIAL TROPONIN RESULT = 59 NG/L, SERIAL BLOOD DRAWS 2 HOURS APART RESULTS = 276 NG/L, 20 NG/L REPEATED SAME INSTRUMENT WITH RESULTS = 29.8 NG/L, 85.0 NG/L, 119.0 NG/L. DRAWS 4 AND 5 ALL BELOW THEIR CUTOFF AT APPROXIMATELY 16 NG/L. ALL DRAWS WERE REPEATED ON SECONDARY INSTRUMENT WITH RESULTS <35 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767993 ↗
• MalfunctionMar 5, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0-35 PG/ML): INITIAL RESULT = 101 PG/ML, REPEAT RESULT ON ANOTHER ARCHITECT = 3.5 PG/ML. ISTAT RESULT = 3.5 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525951 ↗
• InjuryFeb 6, 2024Output Problem; Output Problem

  THE CUSTOMER OBSERVED AN INSTRUMENT ERROR MESSAGE 5301 VACUUM SYSTEM FAILURE GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE. THE CUSTOMER REPORTED AFTER RECEIVING THE ERROR MESSAGE OF 5301, THE ARCHITECT I2000SR PROCESSING MODULE GENERATED MANY UNSPECIFIED ERRORS IN A ROW. THE CUSTOMER REPORTED WHILE THE INSTRUMENT WAS NOT IN USE, THE RELEASE OF LABS WAS AFFECTED CAUSING ONE PATIENT¿S LIVER TRANSPLANT SURGERY TO BE DELAYED 2 HOURS. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE DELAYED LIVER TRANSPLANT. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED AT THIS TIME. UPDATE: ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 19FEB2024. THE TRANSPLANT PATIENT SID IS (B)(6). THE FOLLOWING TESTS WERE ORDERED: SEROLOGY PANEL, HEPATITIS C, B, CHAGAS, SURFACE ANTIGEN, SYPHILIS, HIV. THE PATIENT SAMPLE WAS DRAWN AT 8AM ON (B)(6) 2024 AND THE FOLLOWING RESULTS WERE PROVIDED AT 4PM ON (B)(6) 2024: HIV: 0.34 S/CO. ANTI-HCV: 0.0518 S7CO. CHAGAS: 0.0602 S/CO. SYPHILIS TP: 0.0674 S/CO. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649151 ↗
• MalfunctionDec 1, 2023Smoking; Smoking

  THE CUSTOMER OBSERVED THE ARCHITECT I2000SR PROCESSING MODULE WAS TURNED OFF AUTOMATICALLY WHEN HE ARRIVED AT THE LABORATORY. UPON RESTARTING THE INSTRUMENT, THE MAIN SWITCH TRIPPED AND ALSO FOUND THE BREAKER WAS TRIPPED (VOLTAGE REGULATOR WAS ON BYPASS). THE CUSTOMER RESET THE BREAKER AND WAS TRIPPED AGAIN WHEN ATTEMPTING TO RESTART THE INSTRUMENT. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND DETECTED A BURNING SMELL FROM THE POWER SUPPLY AND CARD CAGE. THE POWER SUPPLY AND CARD CAGE WERE REPLACED AND WHEN TURNING THE INSTRUMENT BACK ON, THE INSTRUMENT SHORTED CAUSING DAMAGE TO THE CARD CAGE CABLE. VISIBLE SMOKE WAS ALSO NOTED. THE COMPONENTS WERE REPLACED, AND THE INSTRUMENT STARTED AND INITIALIZED CORRECTLY. THE FSR NOTED THAT A TRANSFORMER WAS INSTALLED DUE TO THE OUTAGES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO INJURIES TO THE USERS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18249905 ↗
• MalfunctionNov 28, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT TOTAL B-HCG AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT (REFERENCE: = 5.00 MIU/ML IS NEGATIVE, = 25.00 MIU/ML IS POSITIVE, > 5.00 MIU/ML AND < 25.00 MIU/ML ARE CONSIDERED GRAYZONE - NO INTERPRETATION WILL BE REPORTED FOR THESE RESULTS): ON 8 NOV SAMPLE ID (B)(6) RESULT WAS 967.34 MIU/ML (POSITIVE) AND WHEN REPEATED ON 16 NOV THE RESULT WAS <1.2 MIU/ML (NEGATIVE). ON 16 NOV THE SAMPLE WAS TESTED ON ANOTHER PLATFORM AND GENERATED A RESULT OF <5MIU/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222602 ↗
• MalfunctionSep 5, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULTS FOR 1 PATIENT. THE PATIENT¿S NEXT TWO SAMPLES WERE LOWER. THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS ALSO LOWER. THE FOLLOWING DATA WAS PROVIDED: PROCESSED ON (B)(6) 2023 RESULT = 0.13 NG/ML. 2 NEW SAMPLES COLLECTED LATER IN THE DAY AND BOTH RESULTS NEGATIVE ALL 3 SAMPLES REPEATED ON TWO ARCHITECTS AND ALL 6 RESULTS WERE NEGATIVE(NEAR ZERO). TROPONIN REFERENCE RANGE = 0.04 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683109 ↗
• MalfunctionSep 14, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT HCV AG RESULTS GENERATED ON THE ARCHITECT I2000 INSTRUMENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 4.63 FMOL/L, REPEAT 7.12 FMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420172 ↗
• MalfunctionOct 18, 2021False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) ARCHITECT TOTAL B-HCG RESULT ON A PATIENT. RESULTS PROVIDED: SID (B)(6), CARTRIDGE AND RAPID TESTS ARE BOTH NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647842 ↗
• MalfunctionDec 27, 2018False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A (B)(6) ARCHITECT ANTI-HBC II RESULTS FOR 2 PATIENTS ON THE ARCHITECT I2000SR ANALYZER. SAMPLE ID (B)(6): (B)(6) ON AN ALTERNATE ANALYZER. SAMPLE ID (B)(6): (B)(6) ON AN ALTERNATE ANALYZER. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8201131 ↗