ARCHITECT 7K64-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740105945), received between Nov 26, 2019 and Nov 13, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2020Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE CUSTOMER OBSERVED A DECREASE AND IMPRECISION IN ARCHITECT TOTAL T3 PATIENT VALUES WHILE PROCESSING WITH THE REAGENT LOT NUMBERS 13003UI00 AND 15506UI00. FOLLOWING PATIENT DATA WERE PROVIDED BY THE CUSTOMER. REAGENT LOTS 15506UI00 15506UI00 14378UI00: SAMPLE 1 26.09 46.5 64.46, SAMPLE 2 <25.00 35.9 55.9, SAMPLE 3 49.18 56.89, SAMPLE 4 50.49 56.79. SID 17380UI00 15506UI00 13003UI00: (B)(6) 71.07 67.54 40.81, (B)(6) 54.03 52.73 <25.00, (B)(6) 69.84 74.04 44.92, (B)(6) 62.52 75.04 53.6. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10840044 ↗
• MalfunctionNov 12, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TOTAL T3 (TT3) RESULTS ON THREE PATIENTS. THE RESULTS PROVIDED WERE: S1 ARCH = 351 / COBAS = 508; S2 ARCH = <25 / COBAS = 70; S3 ARCH = 33 / COBAS = 100. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10832620 ↗
• MalfunctionJun 17, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TOTAL T3 RESULT ON ONE PATIENT WHILE PROCESSING WITH THE REAGENT LOT 13003UI00. RESULTS PROVIDED: (B)(6) 2020 INITIAL = < 40 NG/DL, REPEAT = 60 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10164860 ↗
• MalfunctionNov 26, 2019Low Readings; Low Readings

  THE CUSTOMER REPORTED CONTROLS OUT OF RANGE LOW FOR ARCHITECT TOTAL T3 (TT3). THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9373913 ↗