ARCHITECT 02R9835Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740175504), received between Nov 16, 2021 and Nov 17, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I AND PROVIDED THE FOLLOWING DATA: A 17 YEAR OLD MALE PRESENTED WITH CHEST PAIN RADIATING TO HIS ARMS. THE PATIENT HAD EKG'S, CARDIAC MRI, AND AN ECHO ALONG WITH BLOOD WORK. THERE WAS NO PATIENT HARM. THE PATIENT WAS DIAGNOSED WITH MYOCARDITIS. THE CUSTOMER REPORTED THAT THE CARDIAC MRI WAS DUE TO TROPONIN RESULT AND EKG AND THAT THE DIAGNOSTIC WORK-UP WAS DUE TO THE SYMPTOMS RELATED TO THE MYOCARDITIS DIAGNOSIS. SAMPLES WERE SENT FOR FURTHER TESTING AND THE RESULTS WERE LOWER AND THE CUSTOMER REPORTED THIS CORRELATED WITH PATIENT EKG, MRI, AND ECHO RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING LABORATORY DATA: ON (B)(6) 2025, SAMPLE ID (B)(6), RESULT WAS >50,000 NG/L. TROPONIN T WAS 145 AND BECKMAN PLATFORM RESULT WAS 6,280 NG/L. ON (B)(6) 2025, SAMPLE ID (B)(6), RESULT WAS 820 NG/L. TROPONIN T WAS 18 AND BECKMAN PLATFORM RESULT WAS 26.1 NG/L. PATIENT NORMAL RANGES: MALE 4 - 34 NG/L. . THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570027 ↗
• MalfunctionMay 30, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I AND PROVIDED THE FOLLOWING DATA: PATIENT INFORMATION: 40-YEAR-OLD FEMALE. PATIENT PAST MEDICAL HISTORY INCLUDES TREATMENT FOR SYPHILIS. THE PATIENT ALSO HAS HAD A NON-PRODUCTIVE COUGH FOR THE PAST MONTH. ON (B)(6) 2025, THE PATIENT PRESENTED WITH CHEST DISCOMFORT, SHORTNESS OF BREATH, AND A FEELING OF NERVOUS/ANXIETY. EKG SHOWED NORMAL SINUS RHYTHM, NONSPECIFIC T WAVE ABNORMALITY, INVERTED T WAVE III AND IT WAS DETERMINED THAT THE EKG AS ABNORMAL. INITIAL TROPONIN WAS 17, 380 AND REPEAT ON 15 MAY WAS 12,000 (CUSTOMER NORMAL RANGE <18). THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LAB, WHICH THE PATIENT REPORTEDLY HAD A NEGATIVE CATH RESULT. ADDITIONAL INFORMATION: PATIENT ALSO HAD ELEVATED D-DIMER FOR WHICH CTA OF THE THORAX WAS PERFORMED WHICH SHOWED: NO EVIDENCE OF PULMONARY EMBOLISM, MULTIFOCAL BILATERAL MILD GROUND GLASS OPACITIES WITH ASSOCIATED AREAS OF BRONCHIAL WALL THICKENING, SUGGESTIVE OF AN INFECTIOUS OR INFLAMMATORY PROCESS/ BRONCHIOLITIS. CLINICAL CORRELATION RECOMMENDED. THE DOCTOR CALLED QUESTIONING THE RESULT AFTER THE NEGATIVE CATH LAB. THE CUSTOMER THEN SENT THE SAMPLE TO

  Patient problems: Cardiac Enzyme Elevation

  MAUDE report 22114716 ↗
• MalfunctionNov 8, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT ON A 68-YR OLD FEMALE PATIENT WHO PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) ¿ (B)(6) 2023 13:35 = 388 NG/L, REPEATED SAME SAMPLE AT 19:26 = < 4 NG/L. SUBSEQUENT DRAWS: SID - DATE/TIME COLLECTED RESULT (B)(6) ¿ (B)(6) 2023 14:35, 4 NG/L. (B)(6) ¿ (B)(6) 2023 15:40 , 4 NG/L. NORMAL REFERENCE RANGE: FEMALE <18 NG/L THE PATIENT HAD AN ABNORMAL ECG T-WAVE. PATIENT WAS ADMINISTERED THE FOLLOWING: ASPIRIN, PLAVIX, HEPARIN DRIP FOR MANAGEMENT OF ACS. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITH A DISCHARGE CONDITION OF: GOOD. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18090784 ↗
• MalfunctionMar 25, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE POSITIVE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULT FOR A PATIENT SAMPLE WHILE RUNNING ON THE ARCHITECT I2000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2022 SID (B)(6): INITIAL TROPONIN-I RESULT: 116 NG/L (CUSTOMER¿S CUTOFF > 35NG/L; REPEAT ON ANOTHER ARCHITECT: 7.4 NG/L; RE-CENTRIFUGED SAMPLE AND REPEATED ON ORIGINAL ANALYZER: 7.8 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13906229 ↗
• MalfunctionNov 16, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I RESULTS FOR SEVERAL PATIENTS. THE ELEVATED RESULTS WERE STILL ELEVATED AFTER REPEAT TESTING AND WERE QUESTIONED BY PHYSICIANS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12823682 ↗