ARCHITECT 08K4128Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380740169824), received between Mar 25, 2020 and Mar 19, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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.

• MalfunctionMar 19, 2026High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT INSULIN RESULT FOR A 35 YEAR OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6): INITIAL RESULT WAS >300 UU/ML, REPEAT WITH 1:2 AUTOMATIC DILUTION WAS >600 UU/ML THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHICH GENERATED A RESULT OF 13.20 UU/ML WITH ROCHE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638965 ↗
• MalfunctionNov 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT INSULIN AND PROVIDED THE FOLLOWING DATA FOR A 49-YEAR-OLD FEMALE PATIENT: ON (B)(6) 2025 SAMPLE ID (B)(6) RESULT WAS >300 U/ML. THE NEXT DAY 1:2 DILUTION RESULT WAS >600 U/ML. THE SAMPLE WAS SENT TO ANOTHER TESTING CENTER, AND GENERATED A RESULT OF 18.10 U/ML. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500769 ↗
• MalfunctionJan 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT INSULIN RESULTS WHICH QUESTIONED BY THE PHYSICIAN FOR A MALE PATIENT FROM DIFFERENT DRAWS. THE PHYSICIAN STATED THE PATIENT TAKING TREATMENT AND INSULIN RESULTS SHOULD BE WITHIN REFERENCE RANGE. THE FOLLOWING DATA WAS PROVIDED: ON 16NOV2023 SID (B)(6) = > 300 U/ML /REDRAWN AND REPEATED SID 231106595302= > 300 U/ML /REDRAWN AND REPEATED ON 17NOV2023 SID (B)(6) => 300 U/ML. LABORATORY REFERENCE RANGE FOR INSULIN=2 TO 20 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427066 ↗
• MalfunctionDec 28, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT INSULIN RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (UNIT UIU/ML): SID (B)(6) INITIAL RESULT 224.4 (RUN ON (B)(6) 2023 AT 11:20AM), RERUN 186.4, NEW SAMPLE RESULT 15.4 (ON (B)(6) 2023 10:23AM). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18412979 ↗
• MalfunctionDec 11, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT INSULIN RESULTS FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 PATIENT 1 SAMPLE ID (B)(6) ALL OF THE FOLLOWING RESULTS WERE GENERATED ON LOT 54221LP21: INITIAL RESULT = 554 U/ML, REPEAT RESULT 1:2 DILUTION = 757 U/ML, REPEAT RESULT LATER = 739.87 U/ML, LAST DILUTED RESULT = 375 U/ML. (B)(6) 2023 SAME PATIENT, NEW SAMPLE. UNDILUTED RESULT WITH LOT 55221LP22 = 146 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300672 ↗
• MalfunctionDec 11, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT INSULIN RESULTS FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 PATIENT 1 SAMPLE ID (B)(6) ALL OF THE FOLLOWING RESULTS WERE GENERATED ON LOT 54221LP21 : INITIAL RESULT = 554 U/ML, REPEAT RESULT 1:2 DILUTION = 757 U/ML, REPEAT RESULT LATER = 739.87 U/ML, LAST DILUTED RESULT = 375 U/ML. (B)(6) 2023 SAME PATIENT, NEW SAMPLE. UNDILUTED RESULT WITH LOT 55221LP22 = 146 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300489 ↗
• MalfunctionNov 2, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT INSULIN, WHICH WAS NOT CONSISTENT WITH PATIENT'S CLINICAL PRESENTATION AND/OR HISTORY AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: INSULIN LABORATORY RESULTS: (UNIT OF MEASURE IS UU/ML) (B)(6) 2023 RESULT WAS 144.5, 12 OCT 2023 RESULT WAS 130.6, 23 OCT 2023 RESULT WAS 123.2, ROCHE RESULT WAS 22.91 (DATE UNKNOWN). OTHER LABORATORY RESULTS: A1C = 6.8%, FASTING GLUCOSE = 154.71, INSULIN RESISTANCE = 8.8. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058912 ↗
• MalfunctionMar 25, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT INSULIN RESULT FOR A (B)(6) YEAR OLD PATIENT. THE FOLLOWING DATA WAS PROVIDED: 06MAR2020 SID SLI04904700 INITIAL RESULT = 84.8 IU/ML, PREVIOUS SAMPLE 04MAR2020 RESULT = 54.7 IU/ML, ADDITIONAL DATA PROVIDED FOR GLUCOSE = 113 WITHOUT FASTING WITH A HISTORY OF 89 AND 98 FASTING. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9881724 ↗