ARCHITECT 07K6427Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00380740144869), received between Nov 6, 2018 and Jul 29, 2021 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Low Readings” (16 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2021Low Readings; Low Readings

  THE CUSTOMER OBSERVED NON-ABBOTT QUALITY CONTROLS FOR TOTAL T3 (TT3) WAS RUNNING OUT OF RANGE LOW AND ERRATIC WHILE PROCESSING WITH THE REAGENT LOT NUMBER 20513UI00 ON THE ARCHITECT ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246475 ↗
• MalfunctionFeb 4, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISION WITH BIO-RAD QUALITY CONTROLS FOR ARCHITECT TOTAL T3 (TT3) WHILE PROCESSING WITH REAGENT LOT 16304UI00. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282517 ↗
• MalfunctionMar 23, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED QUALITY CONTROLS SHIFTED LOW FOR TOTAL T3(TT3) WHEN PROCESSING WITH THE REAGENT LOT 08343UI00 ON THE ARCHITECT I2000SR ANALYZER. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9869233 ↗
• MalfunctionFeb 26, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED BIO-RAD QUALITY CONTROLS SHIFTED DOWN & RLU CALIBRATION WAS LOW FOR TOTAL T3(TT3) WHILE PROCESSING WITH THE REAGENT LOT NUMBER 03496UI00 ON THE ARCHITECT I1000SR ANALYZER. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9758986 ↗
• MalfunctionDec 13, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TOTAL T3 (TT3) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2019 SID (B)(4) = 32.10 / <25.00NG/DL WITH LOT 06423UI00. THE CUSTOMER STATED THAT CONTROLS WERE ALSO TRENDING LOW WITH THIS LOT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9467847 ↗
• MalfunctionSep 23, 2019Low Readings; Low Readings

  THE CUSTOMER OBSERVED CONTROLS OUT OF RANGE LOW, WHEN PROCESSING ARCHITECT TOTAL T3 REAGENT. THERE WERE NO DISCREPANT PATIENT RESULTS PROVIDED. THERE HAS BEEN NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9104461 ↗
• MalfunctionMay 21, 2019Low Test Results; Low Test Results

  CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TOTAL T3 PATIENT RESULTS WHEN USING A 6 POINT ASSAY.. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8629143 ↗
• MalfunctionApr 9, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TOTAL T3 RESULTS ON ONE PATIENT. THE CUSTOMER ALSO STATES THAT THE PEER GROUP FOR THE ABBOTT PRODUCT IS AVERAGING 2 SDS BELOW THE OTHER METHODS. THERE WERE NO ACTUAL PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8495916 ↗
• MalfunctionMar 21, 2019Low Readings; Low Readings

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

  Patient problems: No Patient Involvement

  MAUDE report 8441263 ↗
• MalfunctionMar 4, 2019Low Test Results; Low Test Results

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

  Patient problems: No Patient Involvement

  MAUDE report 8386756 ↗
• MalfunctionFeb 20, 2019Low Test Results; Low Test Results

  CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TOTAL T3 RESULTS ON 5 PATIENTS. THE RESULTS PROVIDED WERE: SID (B)(6) = 0.57 NG/ML; SID (B)(6) = 0.56 NG/ML; SID (B)(6) = < 0.40 NG/ML; SID (B)(6) = 0.59 NG/ML; SID (B)(6) = 0.52 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8355133 ↗
• MalfunctionJan 15, 2019Low Readings; Low Readings

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

  Patient problems: No Patient Involvement

  MAUDE report 8250795 ↗
• MalfunctionJan 8, 2019Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED RESULTS WHILE USING THE ARCHITECT TOTAL T3 ASSAY. THE CUSTOMER INDICATED 4 PATIENT SAMPLES, 2 RESULTS WERE < 0.40, AND TWO ADDITIONAL RESULTS WERE 0.53 AND 0.48. THERE HAS BEEN NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8228543 ↗
• MalfunctionDec 18, 2018Low Readings; Low Readings

  CUSTOMER REPORTED ARCHITECT TOTAL T3 CONTROLS OUT OF RANGE. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8175467 ↗
• MalfunctionDec 17, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED TOTAL T3 RESULTS ON THE ARCHITECT I1000SR ANALYZER. INITIAL DATA OF <0.4 WAS PROVIDED FOR 3 PATIENTS. NO REPEAT DATA WAS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8171558 ↗
• MalfunctionDec 17, 2018Low Readings; Low Readings

  CUSTOMER REPORTED ARCHITECT TOTAL T3 PATIENT RESULTS AND CONTROLS ARE TRENDING LOW. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8170853 ↗
• MalfunctionDec 12, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED MULTIPLE FALSELY DEPRESSED TOTAL TRIIODOTHYRONINE (TOTAL T3) RESULTS WHILE USING ARCHITECT TOTAL T3 REAGENTS. THE FOLLOWING DATA WAS PROVIDED. THE CUSTOMER STATED MULTIPLE RESULTS WERE LESS THAN 0.04 U/ML. SID (B)(6) INITIAL <0.4 U/ML, REPEAT USING IMMULITE METHOD 0.51 U/ML. SID (B)(6) INITIAL <0.4 U/ML, REPEAT USING IMMULITE METHOD 0.52 U/ML. SID (B)(6) INITIAL 0.7 U/ML, REPEAT USING IMMULITE METHOD 1.25 U/ML. SID (B)(6) INITIAL 0.67 U/ML, REPEAT USING IMMULITE METHOD 1.19 U/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8156643 ↗
• MalfunctionDec 7, 2018Low Readings; Low Readings

  THE CUSTOMER REPORTED IMPRECISE CONTROLS WHEN USING THE ARCHITECT TOTAL T3 REAGENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8142798 ↗
• MalfunctionDec 6, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRATIC AND IMPRECISE PATIENT RESULTS OF LESS THAN 40 WHILE USING THE ARCHITECT TOTAL T3 FOR NORMAL THYROID FUNCTION TESTING PROFILE. NO SPECIFIC PATIENT RESULTS WERE PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8139577 ↗
• MalfunctionDec 6, 2018Low Readings; Low Readings

  THE CUSTOMER REPORTED CONTROLS OUT OF RANGE WHILE USING THE ARCHITECT TOTAL T3 REAGENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8139146 ↗
• MalfunctionDec 6, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSE LOW ARCHITECT TOTAL T3 RESULTS FOR 8 PATIENTS. THE FOLLOWING TOTAL T3 RESULTS WERE PROVIDED: PATIENT 1: < 0.4 NG/ML; PATIENT 2: 0.47 NG/ML; PATIENT 3: 0.49 NG/ML PATIENT 4: 0.42 NG/ML; PATIENT 5: 0.46 NG/ML; PATIENT 6: < 0.4 NG/ML; PATIENT 7: < 0.4 NG/ML; PATIENT 8: 0.46 NG/ML. ADDITIONAL RESULTS PROVIDED: PATIENT 1: (B)(6); PATIENT 2: (B)(6); PATIENT 3: (B)(6); PATIENT 4: (B)(6); PATIENT 5: (B)(6); PATIENT 6: (B)(6); PATIENT 7: (B)(6); PATIENT 8: (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8138013 ↗
• MalfunctionDec 6, 2018Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TOTAL T3 RESULTS ON THE ARCHITECT I1000SR ANALYZER. THE RESULTS RANGED FROM <0.4 NG/ML - 0.61 NG/ML WITH THE ARCHITECT TOTAL T3 6-POINT REAGENT, AND 0.4 NG/ML - 1.03 NG/ML WITH THE ARCHITECT TOTAL T3 2-POINT REAGENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8137778 ↗
• MalfunctionDec 4, 2018Low Readings; Low Readings

  THE CUSTOMER OBSERVED MULTIPLE IMPRECISE CONTROLS WHILE USING THE ARCHITECT TOTAL T3 REAGENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8128446 ↗
• MalfunctionNov 20, 2018Low Readings; Low Readings

  THE CUSTOMER REPORTED IMPRECISE CONTROL RESULTS WHEN USING THE ARCHITECT TOTAL T3 REAGENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8092180 ↗
• MalfunctionNov 14, 2018Low Readings; Low Readings

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

  Patient problems: No Patient Involvement

  MAUDE report 8070870 ↗