ARCHITECT 8K41-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740017569), received between May 3, 2018 and Jul 15, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2020High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSE ELEVATED ARCHITECT INSULIN OF 358 AND 376 PMOL/L ON A NON-DIABETIC PATIENT ((B)(6) YEAR OLD EUROPEAN, GENDER NOT PROVIDED). TWO ADDITIONAL SAMPLES FROM THE PATIENT GENERATED ARCHITECT INSULIN OF 120 AND 75 PMOL/L. THE 3 PATIENT SAMPLES WERE PROCESSED ON ANOTHER ARCHITECT ANALYZER WITH VALUES OF 371.7, 92, 71 PMOL/L. THE ACCOUNT USES A NORMAL INSULIN RANGE OF 17.8 TO 173 PMOL/L. THE PATIENT HISTORY WAS (B)(6) SINCE 1991 WITH TRIPLE THERAPY TREATMENT AND HAS NORMAL TPSA AND GLYCEMIA RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10281037 ↗
• MalfunctionMay 3, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT AN INITIAL ARCHITECT INSULIN RESULT OF 399.7 PMOL/L WAS GENERATED ON A (B)(6) PATIENT SAMPLE. THE SAMPLE WAS NOT REPEATED AT THE TIME. THE PATIENT QUESTIONED THE RESULT AS SHE HAD HER BLOOD DRAWN AT ANOTHER HOSPITAL ON A DIFFERENT DAY AND THE RESULTS WERE 20 PMOL/L. THE METHOD WAS UNKNOWN. THE ORIGINAL SAMPLE HAD BEEN DISPOSED AND IS NOT AVAILABLE. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7485180 ↗