ARCHITECT 02R9825Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740175498), received between Mar 7, 2023 and Nov 16, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR ONE MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (NORMAL PATIENT RANGE MALE 0 - 0.033 NG/ML): SID (B)(6) INITIAL RESULT 0.316 NG/ML, REPEATED 0.022 / 0.033 / 0 / 0 / 0 / 0.008 NG/ML. REPEATED ON DIFFERENT ARCHITECT WITH A RESULT OF 0 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18152908 ↗
• MalfunctionMar 7, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT STAT TROPONIN-I RESULT FOR ONE PATIENT SAMPLE ON THE ARCHITECT I2000SR, SERIAL NUMBER (B)(4). THE SAMPLE WAS REPEATED AND THE RESULT WAS IN THE CUSTOMERS NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 21 NG/L, REPEAT RESULTS ON ISR64746 <4, <4, AND <4 RESULT FROM ANOTHER ANALYZER = <4 NG/L CUSTOMER¿S REFERENCE RANGE IS <4 = NORMAL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495511 ↗