ARCHITECT 3P36-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380740112400), received between Dec 19, 2017 and Jun 28, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT AFP RESULT OF 29.83 NG/ML WAS GENERATED FOR A PATIENT SAMPLE ON (B)(6) 2022. THE SAME SAMPLE TUBE WAS RETESTED ON (B)(6) 2022 AND THE RESULT WAS 2.53 NG/ML. THE SAMPLE WAS TESTED ON A DIFFERENT ARCHITECT WHICH CONFIRMED THE LOWER RESULT (2.6 AND 2.67 NG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14846941 ↗
• MalfunctionSep 4, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT ALPHA - FETOPROTEIN (AFP) RESULTS WERE GENERATED ON THE ARCHITECT I2000SR FOR A FEMALE PATIENT DURING PHYSICAL EXAMINATION. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL RESULT 184.32 NG/ML, RETEST RESULT 2.23 NG/ML [REFERENCE RANGE = 0 - 8.78 NG/ML]. ON 08SEP2020, THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT ALPHA-FETOPROTEIN RESULTS WERE GENERATED FOR 2 MORE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: 54 YEAR OLD MALE- INITIAL RESULT 282.08 NG/ML, RETEST RESULT 4.10 NG/ML. 49 YEAR OLD MALE- INITIAL RESULTS 89.81 NG/ML, RETEST RESULT 4.06 NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10497423 ↗
• MalfunctionMay 22, 2020High Test Results; High Test Results

  THE CUSTOMER STATED THAT AN INITIAL ARCHITECT AFP RESULT OF 97.70 NG/ML WAS GENERATED FOR A PATIENT SAMPLE (ID (B)(6)) THAT RETESTED AT 7.97/8.59 NG/ML (ID 10184). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10084032 ↗
• MalfunctionNov 22, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT AFP RESULT FOR A (B)(6) FEMALE GASTROENTEROLOGY PATIENT. SAMPLE ID (B)(6) GENERATED AN INITIAL RESULT OF 1869.1 NG/ML AND RETEST OF 5.1 NG/ML. THE PATIENT ALSO HAD A PREVIOUS HISTORY OF 5.2 NG/ML. NO INFORMATION ON THE PATIENT'S DIAGNOSIS OR CLINICAL PRESENTATION WAS AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9363346 ↗
• MalfunctionAug 12, 2019High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT AFP RESULT ON ONE PATIENT. RESULTS PROVIDED: (B)(6) 2019 SID (B)(6) = 33.06 NG/ML / 3.12 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8884410 ↗
• MalfunctionJun 7, 2019High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ARCHITECT AFP RESULT OF 43.89 NG/ML WAS GENERATED FOR A PATIENT SAMPLE THAT RETESTED AT 1.88 NG/ML. THE CUSTOMER'S NORMAL RSNGE IS 0.89 - 8.78 NG/ML. THE ELEVATED RESULT DOES NOT FIT THE CLINICAL PICTURE. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8680621 ↗
• MalfunctionNov 8, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALPHA-FETOPROTEIN (AFP) RESULTS WHILE USING ARCHITECT AFP REAGENTS. THE FOLLOWING DATA WAS PROVIDED FOR THE SAME PATIENT. INITIAL SID (B)(6) 53.53 NG/ML. REPEAT SID (B)(6) 4.19 NG/ML. THE PATIENT WAS BEING TESTED AFTER A TUMOR SURGERY. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8052932 ↗
• MalfunctionOct 22, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 1669.30NG/ML, REPEATED AFTER A NEW DRAW 3.88, 3.66, 4.23NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7993040 ↗
• MalfunctionSep 11, 2018High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALPHA 1 FETOPROTEIN (AFP) RESULTS ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 23.84 NG/ML, REPEAT 2.23 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7865803 ↗
• MalfunctionDec 19, 2017High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED AFP RESULT ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 4, REPEATED AN ALIQUOT AT 1704, AND AGAIN FROM THE ORIGINAL SAMPLE AS 3 NG/ML AND 4 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130508 ↗