ARCHITECT 02K4539Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740145385), received between Jun 17, 2019 and Aug 15, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT CA 125 II RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE PATIENT SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED: CA125 = 28.9 U/ML, ADDITIONAL LABORATORY DATA PROVIDED: CEA: 21.6 NG/ML, WBC: 25,000, CRP:± THE PATIENT¿S PREVIOUS VALUES WITH THE SAME PLATFORM: (B)(6) CA125 = 271 U/ML, CEA: 12.2 NG/ML, CRP: ± (B)(6) CA125 = 239 U/ML, CEA: 11.4 NG/ML, CRP: 1+ THE CUSTOMER REPORTED THE PATIENT IS ELDERLY UNDERGOING STEROID TREATMENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548138 ↗
• MalfunctionSep 16, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DEPRESSED ARCHITECT CA125 II RESULTS FOR A FEMALE PATIENT DIAGNOSED WITH OVARIAN CANCER AND BEING MONITORED FOR TREATMENT EFFICACY WHILE RUNNING ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED (NORMAL REFERENCE RANGE FOR CA125: 35 U/ML OR LESS): ON (B)(6) 2022, SID (B)(4). RESULT: 23.40 U/ML DUE TO THE HISTORY OF THE PATIENT AT THE TESTING CENTER, IT WAS DISCOVERED THE PATIENT¿S PREVIOUS MEASUREMENT GENERATED A HIGH VALUE (JULY: RESULT WAS AROUND 740 U/ML) WHILE THE SAMPLE TESTED ON AUGUST 10, 2022, WAS WITHIN THE NORMAL RANGE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15440488 ↗
• MalfunctionJun 17, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CA 125 II RESULT FOR A PATIENT UNDERGOING TREATMENT FOR OVARIAN CANCER. THE FOLLOWING RESULTS WERE PROVIDED FOR THE PATIENT: ON (B)(6) 2019: 68 U/ML. ON (B)(6) 2019: 2738 U/ML. ON (B)(6) 2019: 1560 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8706156 ↗