ARCHITECT 2K91-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740137304), received between Jun 26, 2018 and Jun 13, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT CA 19-9 RESULTS FOR ONE PATIENT DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024, SID (B)(6) WAS SENT FROM AN OUTPATIENT FACILITY. THE ARCHITECT CA 19-9 RESULT WAS <2 U/ML, REPEATED <2 U/ML. ON (B)(6) 2024, THE SAME PATIENT WITH DIFFERENT SID (SID (B)(6) WAS SENT FROM AN OUTPATIENT FACILITY. THE ARCHITECT CA 19-9 RESULT WAS 40,243 U/ML. THE CUSTOMER RETESTED THE SAMPLE FROM (B)(6) 2024, (SID (B)(6) AND THE RETEST WAS 30,360 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527385 ↗
• MalfunctionDec 27, 2019Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ARCHITECT CA 19-9XR RESULT FOR 1 PATIENT WHO IS DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: 0 TO 37 U/L): SID (B)(6) INITIAL RESULT = >1200 U/L, REPEAT WITH 1:10 AUTODILUTION = 166 U/L. SAMPLE WAS REPEAT TWICE WITHOUT A DILUTION = >1200 U/L FOR BOTH RUNS, REPEATED TWICE WITH 1:10 AUTODILUTION = 1522 U/L AND 1390 U/L. PREVIOUS CA19-9 RESULT FROM NOVEMBER WAS HIGH. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9526086 ↗
• MalfunctionMay 1, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED CA19-9 RESULTS WHILE USING THE ARCHITECT CA19-9XR ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: ON (B)(6) 2019: SID (B)(6): INITIAL: 251.66 U/ML, RETEST: 3.6 U/ML. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8570272 ↗
• MalfunctionJun 26, 2018High Test Results; High Test Results

  THE FOLLOWING DATA WAS PROVIDED FROM THE ARCHITECT SID (B)(6) INITIAL 1865.3 U/ML. WHICH WAS COMPARED TO A RESULT FROM ANOTHER METHOD: 500 U/ML. THERE IS NO INFORMATION ON THE PATIENTS CLINICAL HISTORY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7638655 ↗