ARCHITECT 07K68-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380740112424), received between Apr 12, 2018 and Jun 10, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 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.

• MalfunctionJun 10, 2022Low Test Results; Low Test Results

  THE CUSTOMER SUSPECTS FALSELY DEPRESSED ARCHITECT CEA AND ARCHITECT CA 19-9XR RESULTS FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6)2021: CEA: 11.3 NG/ML / CA19-9 RESULT: 246.2 U/ML ON (B)(6)2022: CEA: 16.3 NG/ML / CA 19-9 RESULT: 166.6 U/ML ON (B)(6)2022 SID(B)(6): CEA RESULT: 4.38 NG/ML, CA 19-9 RESULT: 22.32 U/ML RETESTED ON (B)(6)2022: CEA RESULT: 4.42 NG/ML, CA 19-9 RESULT: 26.5 U/ML THE PATIENT¿S CLINICAL HISTORY IS UNKNOWN AND DOCTOR SUSPECTS MAY¿S RESULTS ARE LOW. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658197 ↗
• MalfunctionApr 25, 2022Low Test Results; Low Test Results

  THE CUSTOMER IDENTIFIED FALSELY DEPRESSED ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) RESULTS FOR ONE PATIENT. THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION: CEA (B)(6) 2022 SID: (B)(6) GENERATED WITH SERIAL NUMBER (B)(4) RESULT 80.25 NG/ML WITH REAGENT LOT 29180FN00; GENERATED WITH SERIAL NUMBER (B)(4) RESULT < 0.50 NG / ML WITH REAGENT LOT 29180FN00, RETEST 1:1 79.80 NG/ML AND 84.3 NG/ML. THE CUSTOMER REPORTED RESULTS AS 80.25 NG/ML. PATIENT HISTORY: (B)(6) 2022 12.3 NG/L. THE PATIENT IS A (B)(6) FEMALE WITH A MALIGNANT TUMOR; THE CUSTOMER IS NOT AWARE OF WHAT KIND OF CANCER THE PATIENT HAS BEEN DIAGNOSED WITH. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191550 ↗
• MalfunctionDec 17, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) RESULTS FOR A 67 YEAR OLD MALE DIAGNOSED WITH DIGESTION VISCERAL CANCER. THE FOLLOWING DATA WAS PROVIDED: 01DEC2021 SID (B)(6) INITIAL RESULT WAS >1500 NG/ML, REPEAT = 9.7 NG/ML, REPEAT WITH A DILUTION = 2114.7 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13028546 ↗
• MalfunctionJul 19, 2019Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT A FALSELY DECREASED ARCHITECT CEA RESULT WAS GENERATED FOR A PATIENT SAMPLE (ID (B)(6)). THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT: 316.60 NG/ML. RETEST 1: 0.5 NG/ML. RETEST 2: 315.32 NG/ML. RETEST 3: 316.72 NG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809765 ↗
• InjuryJan 30, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT CEA RESULT. THE SAMPLE GENERATED A RESULT OF 50.3 NG/ML. THE PATIENT'S PREVIOUS RESULT WAS 28.1 NG/ML. THE CUSTOMER INDICATED THE PATIENT HAD A PET-CT, COLON FIBERSCOPE AND GASTROSCOPY DUE TO THE ELEVATED CEA RESULTS. THERE WAS NO ADVERSE IMPACT TO THE PATIENT DUE TO THE PROCEDURES.

  Patient problems: No Code Available

  MAUDE report 8289790 ↗
• MalfunctionDec 3, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED RESULTS WHILE USING ARCHITECT CEA (CARCINOEMBRYONIC ANTIGEN) REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR THE SAME PATIENT. SID (B)(6) (TESTED (B)(6) 2018) INITIAL 11.36 NG/ML, REPEAT 10.92 NG/ML. PREVIOUS RESULTS TESTED ON (B)(6) 2018 WERE LOWER, SID (B)(6) INITIAL 22.94 NG/ML, REPEAT 23.76 NG/ML. THE PATIENT WAS DIAGNOSED WITH CANCER; HOWEVER, THE SPECIFIC CANCER DIAGNOSIS WAS NOT PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8126684 ↗
• MalfunctionOct 24, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED POOR REPRODUCIBILITY AND FALSELY DEPRESSED RESULTS WHILE USING ARCHITECT CEA REAGENTS. THE FOLLOWING DATA WAS PROVIDED. PATIENT 1 SID (B)(6) REPEAT USING ANALYZER SN (B)(4) 4.9 IU/ML, INITIAL VALUE WAS HIGHER USING ANOTHER ANALYZER (SN (B)(4)) 937 IU/ML. PATIENT 2 SID (B)(6) REPEAT USING ANALYZER SN (B)(4) 0.5 IU/ML, INITIAL AND REPEAT VALUES WERE HIGHER USING ANOTHER ANALYZER (SN (B)(4)) 5.4, 5.63 IU/ML. PATIENT 3 SID (B)(6) REPEAT USING ANALYZER SN (B)(4) 0.5 IU/ML, INITIAL VALUE WAS HIGHER USING ANOTHER ANALYZER (SN (B)(4)) 4.9 IU/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8003074 ↗
• MalfunctionApr 12, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED ERRATIC RESULTS WHILE USING THE ARCHITECT CEA ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS DATA: ON (B)(6) 2018 CEA INITIAL 0.5, RETEST 4.4 NG/ML THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7426437 ↗