ARCHITECT 02K4529Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380740145378), received between Jan 31, 2019 and Feb 15, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2021High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT CA 125 RESULT OF 40.72 U/ML WAS GENERATED FOR A PATIENT SAMPLE THAT RETESTED AT 25.21 U/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330008 ↗
• MalfunctionJul 14, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT CA 125 II RESULT ON AN (B)(6) FEMALE PATIENT DIAGNOSED WITH OVARIAN CANCER AND SQUAMOUS CELL CARCINOMA. RESULTS PROVIDED: (B)(6) 2020 = 17.0 U/ML; (B)(6) 2020 = 30.3 U/ML; (B)(6) 2020 = 99.2 U/ML; (B)(6) 2020 = 9.0 U/ML (REFERENCE RANGE: <35.0 U/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10269889 ↗
• MalfunctionJan 2, 2020High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT CA125 OF 83.80 U/ML ON (B)(6) 2019 WITH A FEMALE, (B)(6) PATIENT WITH ENDOMETRIAL CANCER. HISTORICALLY, THE PATIENT HAD CA125 OF 16.5 U/ML AND HAD A TOTAL HYSTERECTOMY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO ETHNICITY OR RACE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9542045 ↗
• MalfunctionNov 19, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA125 RESULTS ON ONE (B)(6) FEMALE DIAGNOSED WITH OVARIAN SEROUS CYSTIC TUMOR. THE RESULTS PROVIDED WERE: (B)(6) 2019 CA125 = 84.2U/ML / (B)(6) 2019 OVARECTOMY AND SURGERY TO REMOVE TUMOR / (B)(6) 2019 CA125 = 295.5U/ML; ON (B)(6) 2019 CEA = 0.8 NG/ML AND CA19-9 = 7.1 U/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9342069 ↗
• MalfunctionAug 5, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA 125 RESULTS ON ONE PATIENT DIAGNOSED WITH OVARIAN CANCER. THE RESULTS PROVIDED WERE: PT#1: ON (B)(6) 2017 = 85.6U/ML; ON (B)(6) 2017 = 74.3U/ML; ON (B)(6) 2019 = 665.7 U/ML, SAMPLE WAS RE-SPUN AND RETESTED = 674.9 AND 665.7U/ML; ON (B)(6) 2019 = 81.9 U/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8860768 ↗
• MalfunctionJun 12, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA125 RESULTS ON ONE (B)(6) YEAR OLD FEMALE DIAGNOSED WITH OVARIAN SEROUS CYSTIC TUMOR. THE RESULTS PROVIDED WERE: (B)(6) 2019 CA125 = 84.2U/ML / (B)(6) 2019 OVARECTOMY AND SURGERY TO REMOVE TUMOR / (B)(6) 2019 CA125 = 295.5U/ML; ON (B)(6) 2019 CEA = 0.8 NG/ML AND CA19-9 = 7.1 U/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8693542 ↗
• MalfunctionFeb 1, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED CA125 INITIAL RESULT OF 53.4 U/ML, WHEN PROCESSING ON THE ARCHITECT I2000SR. ANOTHER TUBE FROM THE SAME SAMPLE GENERATED A RESULT OF 14.3 U/ML. THE SAMPLE WAS RETESTED AGAIN AND YIELDED RESULTS OF 55.2 U/ML AND 51.6 U/ML. A SECOND SAMPLE WAS DRAWN AND YIELDED RESULTS OF 42.1 U/ML AND 25.9 U/ML. RESULTS FROM ANOTHER ARCHITECT GAVE A RESULT OF 28 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8296473 ↗
• MalfunctionJan 31, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT CA 125 RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) 2019 ON SERIAL NUMBER (B)(4) = 53.4U/ML / ON SN (B)(4) = 14.3U/ML; REPEATED ON (B)(6) 2019, SN (B)(4) = 55.2U/ML / ON (B)(6) 2019, SN (B)(4) = 51.6U/ML; SECOND SAMPLE DRAWN TESTED ON (B)(4) = 42.1U/ML / (B)(4) = 25.9U/ML; ON ANOTHER ARCHITECT ANALYZER AT A DIFFERENT SITE = 28U/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8293658 ↗