ARCHITECT 07K6432Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380740144876), received between Nov 14, 2018 and Apr 9, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2019Low Readings; Low Readings

  THE CUSTOMER OBSERVED IMPRECISE ARCHITECT TOTAL T3 CONTROLS. THERE WERE NO PATIENT RESULTS PROVIDED. THERE HAS BEEN NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8496899 ↗
• MalfunctionApr 9, 2019Low Readings; Low Readings

  THE CUSTOMER REPORTED CONTROLS SHIFTING DOWN FOR ARCHITECT TOTAL T3 (TT3). THERE WERE NO ACTUAL PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8495984 ↗
• MalfunctionFeb 20, 2019Low Test Results; Low Test Results

  CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TOTAL T3 RESULTS ON FOUR PATIENTS. THE RESULTS PROVIDED: ON (B)(6) 2019 SID (B)(6) = 0.43 NG/ML; ON (B)(6) 2019 SID (B)(6) = 0.43 NG/ML; ON (B)(6) 2019 SID (B)(6) = 0.40 NG/ML; ON (B)(6) 2019 SID (B)(6) = 0.43 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8355102 ↗
• MalfunctionDec 28, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED TOTAL T3 RESULTS ON 61 PATIENTS ON THE ARCHITECT ANALYZER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8203341 ↗
• MalfunctionDec 6, 2018Low Readings; Low Readings

  THE CUSTOMER REPORTED CONTROLS SHIFTED DOWN WHILE USING THE ARCHITECT TOTAL T3 6 POINT REAGENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8139045 ↗
• MalfunctionNov 21, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN INCREASE IN FALSELY DECREASED ARCHITECT TOTAL T3 PATIENT RESULTS BETWEEN MAY AND SEPTEMBER. THE CUSTOMER RECEIVED THE PRODUCT CORRECTION LETTER (B)(4)AND SEPARATED THE VITAMIN D ASSAY FROM THE TT3, BUT IS STILL SEEING LOW RESULTS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8095347 ↗
• MalfunctionNov 20, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT TOTAL T3 (TT3) RESULTS ON ELEVEN PATIENTS. THE RESULTS PROVIDED RANGED FROM 45.89-67.59NG/DL (RANGE 64.0-152.0NG/DL) ON THE ARCHITECT AND 53-89NG/DL ON THE ROCHE METHOD (RANGE 70-200NG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8090652 ↗
• MalfunctionNov 14, 2018Low Test Results; Low Test Results

  THE ACCOUNT GENERATED A <40 NG/DL ARCHITECT TOTAL T3 RESULT ON (B)(6) 2018 ON A PATIENT SAMPLE THAT WAS QUESTIONED. THE SAMPLE WAS REPEATED AT ANOTHER LABORATORY WITH A RESULT OF 65 ON (B)(6) 2018. A NEW SAMPLE WAS OBTAINED WITH THE SAME RESULT OF <40 ON (B)(6) 2018. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. ADDITIONAL RESULTS WERE PROVIDED: (B)(6) 2018 FREE T4 = 1.00 NG/DL; TSH = 1.16 UIU/ML (ARCHITECT); (B)(6) 2018 FREE T4 = 0.96 NG/DL (UNIMED); TSH = 1.85 UIU/ML (ARCHITECT); (B)(6) 2018 FREE T4 = 1.04 NG/DL; TSH= 1.19 UIU/ML (ARCHITECT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8070383 ↗