ARCHITECT 8D06-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740117122), received between Sep 17, 2020 and Jul 11, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (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 11, 2024False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULTS FOR A NEWBORN WITH A POSITIVE SYPHILIS MOTHER. THE PATIENT WAS REDRAWN AND THE EXPECTED POSITIVE RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): INITIAL RESULT = 0.87 S/CO SAMPLE WAS A SHORT SAMPLE. REDRAW SID (B)(6) RESULT = 21.62 S/CO NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19723886 ↗
• MalfunctionSep 17, 2020False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED A FALSE NEGATIVE ARCHITECT SYPHILIS TP RESULT. THE SAMPLE GENERATED 0.13 AND RETEST ON SECOND ANALYZER 0.15 S/CO ON ARCHITECT. THE SAMPLE GENERATED POSITIVE RESULTS ON TPPA AND RPR METHODS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10545738 ↗