ARCHITECT 7K64-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 00380740014322), received between Nov 16, 2018 and May 5, 2021 — classified as 130 malfunctions.

The most frequently reported specific device problem is “Low Readings” (83 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 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2021Low Test Results; Low Readings; Low Test Results; Low Readings

  THE CUSTOMER OBSERVED IQC AND PATIENT SAMPLES SHIFTED LOW WHILE PROCESSING WITH THE REAGENT LOT 23219UI00 FOR ARCHITECT TOTAL T3. NO DISCREPANT PATIENT RESULTS WERE GENERATED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778124 ↗
• MalfunctionMar 9, 2021Low Readings; Low Readings

  THE CUSTOMER OBSERVED BIO-RAD QUALITY CONTROLS SHIFTED LOW FOR TOTAL T3 (TT3) WHILE PROCESSING ON THE ARCHITECT WITH REAGENT LOT 23219UI00. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448724 ↗
• MalfunctionFeb 4, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSE DEPRESSED ARCHITECT TOTAL T3 (TT3) RESULT WHILE PROCESSING WITH THE REAGENT LOT 17380UI00. THE CUSTOMER PROVIDED TWO SAMPLES WERE PROCESSED FOR THIS PATIENT. SAMPLE ONE RESULTS = 53.06 NG/DL, RETESTED ON ANOTHER ARCHITECT RESULTS = 52.11 NG/DL. SAMPLE 2 RESULTS = 114.40 NG/DL, REPEAT WAS 120.14 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282564 ↗
• MalfunctionFeb 3, 2021Low Test Results; Low Test Results

  THE CUSTOMER GENERATED FALSELY DEPRESSED ARCHITECT TOTAL T3 RESULTS FOR FOUR PATIENTS IN COMPARISON TO PATIENT HISTORY WHILE PROCESSING WITH THE REAGENT LOT 15453UI00. THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT 1 INITIAL RESULT 0.25 NG/ML, REPEAT 0.40 NG/ML PATIENT 2 INITIAL RESULT 0.25 NG/ML, REPEAT 0.57 NG/ML PATIENT 3 INITIAL RESULT 0.42 NG/ML, REPEAT 0.72 NG/ML PATIENT 4 INITIAL RESULT 0.52 NG/ML, REPEAT 0.67 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11275226 ↗
• MalfunctionJan 4, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT T3, TOTAL RESULTS IN RELATION TO THE THYROID PROFILE ON ONE PATIENT. THERE WERE NO INDIVIDUAL OR COMPARISON RESULTS PROVIDED. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11109075 ↗
• MalfunctionDec 8, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED NON-ABBOTT ARCHITECT TOTAL T3 QUALITY CONTROLS SHIFTED DOWN AND RUNNING ERRATIC WHILE PROCESSING WITH THE REAGENT LOT 15453UI00. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10970845 ↗
• MalfunctionDec 5, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TOTAL T3 RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL = 51.45 NG/DL, RETESTED ON ANOTHER ARCHITECT RESULT = 67.26 NG/DL (NORMAL RANGE: 58-159 NG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10952655 ↗
• MalfunctionDec 5, 2020Low 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) 2020 THE PATIENT = <25NG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10950437 ↗
• MalfunctionDec 4, 2020Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A FALSELY DEPRESSED ARCHITECT TOTAL T3 RESULTS FOR 4 SAMPLES. THE CUSTOMER PROVIDED AN EXAMPLE WITH AN INITIAL RESULT OF <0.25 NG/DL AND REPEAT OF 0.32 NG/DL. THE CUSTOMER USES NORMAL RANGE NORMAL RANGE 0.58 - 1.59 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10949800 ↗
• MalfunctionDec 4, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED ERROR CODE 1320 ASSAY (X) NUMBER (Y) CALIBRATION FAILURE ON THE ARCHITECT I1000SR ANALYZER WHILE PROCESSING WITH THE REAGENT LOT 17380UI00. THERE WAS NO SPECIFIC DATA PROVIDED AND NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10949555 ↗
• MalfunctionNov 20, 2020Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT TOTAL T3 RESULTS ON A PATIENT, AND CONTROL WHILE PROCESSING WITH THE REAGENT LOT#: 13236UI00. THERE WAS NO SPECIFIC DATA PROVIDED, AND NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10876096 ↗
• MalfunctionNov 17, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED NON-ABBOTT QUALITY CONTROLS WERE OUT OF RANGE LOW FOR TOTAL T3 WHILE PROCESSING WITH THE REAGENT LOT 11482UI00 ON THE ARCHITECT I1000 SR ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10856323 ↗
• MalfunctionNov 12, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED DEPRESSED ARCHITECT TOTAL T3 RESULTS IN COMPARISON WITH TOTAL T4, AND TSH WHILE PROCESSING WITH THE REAGENT LOT#: 13236UI00. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10832151 ↗
• MalfunctionNov 2, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED NON-ABBOTT QUALITY CONTROLS OUT OF RANGE LOW FOR TOTAL T3 WHILE PROCESSING WITH THE REAGENT LOT 13236UI00 ON THE ARCHITECT I1000 ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10770571 ↗
• MalfunctionOct 30, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED NON-ABBOTT QUALITY CONTROLS SHIFTED LOW FOR TOTAL T3 WHILE PROCESSING WITH THE REAGENT LOT 13236UI00 ON THE ARCHITECT I1000 ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10763168 ↗
• MalfunctionOct 29, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED BIO-RAD QUALITY CONTROLS OUT OF RANGE LOW FOR TOTAL T3 WHILE PROCESSING WITH THE REAGENT LOT 13236UI00 ON THE ARCHITECT I2000 SR ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10755690 ↗
• MalfunctionOct 29, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED NON-ABBOTT QUALITY CONTROLS SHIFTED LOW FOR TOTAL WHILE PROCESSING WITH THE REAGENT LOT 13236UI00 ON THE ARCHITECT I1000 ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10755538 ↗
• MalfunctionOct 29, 2020Low Test Results; Low Test Results

  THE ACCOUNT OBSERVED FALSE DEPRESSED ARCHITECT TOTAL T3 RESULTS WITH 2 SAMPLES USING 2 REAGENT LOTS, RESULTS RECOVERED LOW WITH THE REAGENT LOT 15453UI00. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10755110 ↗
• MalfunctionOct 7, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED FALSELY DEPRESSED PATIENT RESULTS FOR TOTAL T3 WHILE PROCESSING WITH THE REAGENT LOT 13236UI00 ON THE ARCHITECT I2000 SR ANALYZER. NO SPECIFIC PATIENT INFORMATION WAS AVAILABLE, BUT CUSTOMER STATED RESULTS WERE < 0.25, BUT NOT DISCREPANCE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. PER THE PRODUCT PACKAGE INSERT, THE MEASURING INTERVAL LIMIT OF QUANTITATION IS 1.5 PG/ML AND THE RESULTS WERE CORRECTLY FLAGGED WITH A LESS THAN SIGN, <. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10641642 ↗
• MalfunctionSep 24, 2020Low Readings; Low Readings

  THE CUSTOMER REPORTED FALSELY DEPRESSED ARCHITECT TOTAL T3 RESULTS ON THREE PATIENTS. THE RESULTS PROVIDED WERE: FIRST SAMPLE: INITIAL <25 NG/DL, REPEATED 69.18 NG/DL, SECOND SAMPLE: INITIAL <25 NG/DL, REPEATED 54.64 NG/DL, THIRD SAMPLE: INITIAL <25 NG/DL, REPEATED 68.18 NG/DL, (NORMAL RANGE 58 TO 159 NG/DL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. PER THE PRODUCT PACKAGE INSERT, THE MEASURING INTERVAL LIMIT OF QUANTITATION IS 1.5 PG/ML AND THE RESULTS WERE CORRECTLY FLAGGED WITH A LESS THAN SIGN, < NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10583846 ↗
• MalfunctionSep 24, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED BIO-RAD QUALITY CONTROLS OUT OF RANGE FOR HIGH LEVEL FOR TOTAL T3 WHILE PROCESSING WITH THE REAGENT LOT 11482UI00 ON THE ARCHITECT I1000SR ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10583740 ↗
• MalfunctionSep 24, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED TECHNO-PATH QUALITY CONTROLS OUT OF RANGE LOW FOR TOTAL T3 WHILE PROCESSING WITH THE REAGENT LOT13236UI00 ON THE ARCHITECT I1000SR ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10582039 ↗
• MalfunctionSep 24, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED BIO-RAD QUALITY CONTROLS OUT OF RANGE FOR HIGH LEVEL FOR TOTAL T3 WHILE PROCESSING WITH THE REAGENT LOT 11482UI00 ON THE ARCHITECT I1000SR ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10581857 ↗
• MalfunctionSep 24, 2020Low Readings; Low Readings

  THE CUSTOMER OBSERVED LOW AND ERRATIC QUALITY CONTROLS FOR TOTAL T3 WHILE PROCESSING WITH THE REAGENT LOT 11482UI00 ON THE ARCHITECT I1000SR ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10581725 ↗
• MalfunctionSep 21, 2020Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED TOTAL T3 RESULTS WHILE PROCESSING WITH THE REAGENT LOT 09042UI00, ON THE ARCHITECT I1000SR ANALYZER. THE CUSTOMER PROVIDED EXAMPLE FOR ONE SAMPLE, INITIAL RESULT 0.39 NG/ML AND REPEAT RESULT 0.56 NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10559506 ↗