ARCHITECT 2P36-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740003906), received between Aug 24, 2020 and Aug 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Positive Result” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT (B)(6) AG/AB COMBO ASSAY RESULTS FOR A (B)(6) YEAR OLD MALE, WHO IS CURRENTLY TAKING THE MEDICATION TRUVADA. THE PATIENT DOES NOT DESCRIBE ANY RISK FACTORS AND TESTED NEGATIVE FOR (B)(6) IN (B)(6) 2019. THE CUSTOMER PROVIDED THAT ON (B)(6) 2020 RESULTS FOR THIS PATIENT WERE REACTIVE WITH ARCHITECT AND VIA AN ALTERNATE METHOD. ON (B)(6) 2020 SID (B)(6): INITIAL = 38.30 S/CO, REPEATS 58.45, 60.40 S/CO. ON (B)(6) 2020 THE SAMPLE WAS TESTED ON ANOTHER METHOD, GEENIUS: INITIAL TESTING RESULT WAS (B)(6) INDETERMINATE AND (B)(6) NONREACTIVE (GP41 PRESENT ONLY). REPEAT TESTING RESULTS WERE (B)(6) REACTIVE AND (B)(6) NONREACTIVE (GP41 & GP160 PRESENT). ON (B)(6) 2020 SID (B)(6) RESULTS = 0.22, 0.25, & 0.21 S/CO. ON (B)(6) 2020 (B)(6) INITIAL = 0.22 S/CO, REPEATS = 0.25, 0.21 S/CO AND SID (B)(6) INITIAL = 54.68, REPEAT = 52.46 S/CO. ARCHITECT (B)(6) AG/AB COMBO ASSAY INTERPRETATION RANGE: <1.00 S/CO = NONREACTIVE; => 1.00 S/CO = REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10446359 ↗