ARCHITECT 07K68-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740014582), received between Dec 1, 2017 and Nov 18, 2020 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT CEA RESULT FOR A PATIENT. THE PATIENT WAS TESTED PREVIOUSLY AND GENERATED A CEA RESULT OF 50 NG/ML. ON (B)(6) 2020, THE PATIENT SAMPLE WAS TESTED ON THE ARCHITECT I2000SR ANALYZER AND GENERATED A RESULT OF LESS THAN 0.5 NG/ML. THE PATIENT SAMPLE WAS THEN REPEATED ON THE ALINITY I PLATFORM AND GENERATED A RESULT OF 61 NG/ML AND REPEAT RESULT OF 61 NG/ML. THEN THE CUSTOMER REPEATED THE SAMPLE BACK ON THE ARCHITECT I2000SR ANALYZER AND GENERATED A RESULT OF 56 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10864619 ↗
• MalfunctionJan 29, 2020Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT A FALSELY DECREASED ARCHITECT CEA RESULT OF 0.53 NG/ML WAS GENERATED FOR A PATIENT SAMPLE THAT RETESTED AT 3.98 AND 5.15 NG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9643790 ↗
• MalfunctionJun 6, 2019False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A FALSE NEGATIVE ARCHITECT CEA RESULT FOR 1 PATIENT. THE FOLLOWING PATIENT DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = <0.5 NG/ML, REPEAT = 327.55 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8675582 ↗
• MalfunctionDec 1, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CORRECTION FEBRUARY 14, 2018. THE ARCHITECT METHOD RESULTS ARE AS FOLLOWS: SID (B)(6) (TESTED (B)(6) 2017) 2.99 NG/ML, TESTED AT ANOTHER FACILITY USING THE ARCHITECT METHOD 2.79 NG/ML PREVIOUS RESULT FOR THE PATIENT, SID (B)(6) (TESTED (B)(6) 2017) 2.51 NG/ML. NONE OF THE ARCHITECT RESULTS WERE 20 NG/ML.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7075947 ↗