ARCHITECT 07K68-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380740014575), received between Nov 18, 2016 and Dec 27, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2021Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED ARCHITECT CEA RESULTS FOR TWO PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED: PERSON 1: CEA (B)(6) 2021 11:19 RESULT 2.37 NG/ML. CEA (B)(6) 2021 12:02 RESULT 4.74 NG/ML. PERSON 2: CEA (B)(6) 2021 11:41 RESULT 2.24 NG/ML. CEA (B)(6) 2021 12:36 RESULT 6.79 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13091149 ↗
• MalfunctionNov 19, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT CEA RESULTS ON ONE (B)(6) FEMALE PATIENT DIAGNOSED WITH COLON CANCER. THE RESULTS PROVIDED WERE: ON (B)(6) INITIAL= 3.8 NG/ML /REPEATED 1:2 DILUTION=< 5.0 NG/ML /ON (B)(6)=3.9 NG/ML /ON (B)(6) RESULT=53.3 NG/ML /PREVIOUS HISTORY FOR CEA=AROUND 3.0 NG/ML ADDITIONAL INFORMATION PROVIDED: CA19-9 XR=3.2 THE CUSTOMER QUESTIONING THE CEA RESULTS=53.3 NG/ML ON 08SEP. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844939 ↗
• MalfunctionSep 7, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT CEA RESULTS GENERATED ON AN ARCHITECT I2000 PROCESSING MODULE ON A (B)(6) MALE UNDERGOING RADIATION THERAPY FOR LUNG CANCER. THE FOLLOWING RESULTS WERE PROVIDED. SID (B)(6) INITIAL RESULT = 1.47 NG/ML, REPEAT RESULT = 32.63 NG/ML. THE PATIENT HAD BEEN TRENDING AROUND 30 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433509 ↗
• MalfunctionJan 26, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ARCHITECT CEA RESULT OF <0.5 NG/ML FOR A PATIENT SAMPLE THAT RETESTED AT 1130 NG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11230436 ↗
• MalfunctionSep 17, 2020Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT A FALSELY DECREASED ARCHITECT CEA RESULT OF 0.9 NG/ML WAS GENERATED ON (B)(6) 2020, AND DID NOT MATCH THE PATIENT'S HISTORICAL OR SUBSEQUENT TESTING. THE SAMPLE WAS NOT AVAILABLE FOR REPEAT TESTING. SID: (B)(6): 0.9 NG/ML; (B)(6) 2020. SID: (B)(6): 3329.7 NG/ML; (B)(6) 2020. (AGREES WITH PREVIOUS TESTS AND PATIENT HISTORY). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10549756 ↗
• MalfunctionJul 17, 2020Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A FALSELY DEPRESSED ARCHITECT CEA RESULT. SAMPLE 1 GENERATED A RESULT OF 4.69 NG/ML ON THE CURRENT LOT AND WHEN RETESTED ON A NEW LOG GENERATED 6.37 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10290798 ↗
• MalfunctionMar 5, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT CEA RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) DAY 1 ARCHITECT=9NG/ML/ ROCHE = 23NG/ML; DAY 2 ARCH = 19.9NG/ML / ROCHE = 23NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9793537 ↗
• MalfunctionApr 25, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSE DECREASED CEA RESULTS WHEN PROCESSING ON THE ARCHITECT I2000SR FOR SID (B)(6). THE INITIAL RESULT WAS 0.5 AND RETEST WAS 22.0. PREVIOUS RESULTS WERE 15.6 AND 8.5. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549033 ↗
• MalfunctionJan 8, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSE DECREASED ARCHITECT CEA RESULT FOR A RECENTLY DIAGNOSED COLON CANCER PATIENT. THE FOLLOWING CEA RESULTS WERE PROVIDED: 10/18: 6.6 NG/ML; 12/4: 4.8 NG/ML. THE CUSTOMER REPORTS NO TREATMENT WAS DONE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8225989 ↗
• MalfunctionSep 25, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED CEA RESULT WHILE USING THE ARCHITECT CEA ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR ONE PATIENT: INITIAL: 0.58, RETEST 840. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7906232 ↗
• MalfunctionFeb 16, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED CARCINOEMBRYONIC ANTIGEN (CEA) RESULT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 55.7 NG/ML, REPEAT 2.6. THERE WAS NO IMPACT TO THE PATIENT MANAGEMENT OF THIS (B)(6) MALE PATIENT BEING TREATED FOR SIGMOID COLON CANCER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278657 ↗
• MalfunctionJun 15, 2017Low Test Results; False Reading From Device Non-Compliance; Low Test Results

  THE CUSTOMER REPORTED THEY OBTAINED A FALSE DEPRESSED RESULT ON THE ARCHITECT CEA ASSAY WITH REAGENT LOT 72324FN00. SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 3.35 NG/ML AND WHEN REPEATED IN DUPLICATE (SAMPLE ID (B)(6)) GENERATED 149.00 AND 142.16 NG/ML.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6645040 ↗
• MalfunctionNov 18, 2016Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY DECREASED CEA RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL = 5.0 / REPEAT = 15,000. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6112905 ↗