ARCHITECT 8D06-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740117115), received between Oct 20, 2017 and Dec 12, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023False Negative Result; False Negative Result

  THE CUSTOMER OBSERVED A FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULT FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) : ARCHITECT (B)(6) RESULT WAS NONREACTIVE, TITER WAS >256, ARUP RESULT WAS REACTIVE FOR TROUBLESHOOTING PURPOSES ONLY, THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND REPEATED ON ANOTHER ARCHITECT (B)(6) WHICH GENERATED NONREACTIVE RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314130 ↗
• MalfunctionDec 27, 2019False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT (B)(6) TP RESULT AND WAS INQUIRING IF THE ASSAY HAS ANY CROSS REACTIVITY WITH RED CELL ANTIGENS. THE FOLLOWING DATA WAS PROVIDED FOR THE PATIENT IN QUESTION: INITIAL RESULT = 1.71 S/CO (REACTIVE), MHA TP = REACTIVE, RPR = NONREACTIVE. THE PATIENT IS POSITIVE FOR THE "C" ANTIGEN AND RECENTLY DELIVERED A BABY. THE NEWBORN BABY HAD A SPINAL TAP PROCEDURE TO RETRIEVE CEREBROSPINAL FLUID FOR (B)(6) TESTING: ARCHITECT (B)(6) = REACTIVE, RPR = NONREACTIVE, MHA TP = NONREACTIVE, VDRL = NONREACTIVE. THE SPINAL TAP WAS PERFORMED DUE TO THE FALSE REACTIVE ARCHITECT (B)(6) RESULTS ON THE MOTHER'S SAMPLE.

  Patient problems: No Code Available

  MAUDE report 9527284 ↗
• MalfunctionOct 20, 2017False Negative Result; False Negative Result

  THE CUSTOMER REPORTED A FALSE NON-REACTIVE ARCHITECT SYPHILIS TP RESULT FOR ONE POSTPARTUM PATIENT THAT WAS PREVIOUSLY TREATED FOR (B)(6). SAMPLE ID (B)(6) GENERATED A NEGATIVE (0.14 S/CO) RESULT ON THE ARCHITECT ASSAY AND POSITIVE ON THE RPR ASSAY. THE CUSTOMER FURTHER INDICATED THE BABY WAS ALSO POSITIVE ON RPR. NO FURTHER PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6965649 ↗