ARCHITECT 07K6327Recalls & reported problems
Abbott Ireland · ARCHITECT Free T3 Reagent Kit (100T) · Class 2
Quick summary
This Abbott ARCHITECT free thyroid hormone reagent kit is a lab test kit used to measure free thyroid hormone levels. Its 185 reports include no deaths and no injuries. Many describe low readings and imprecise results on quality control samples, and most report no impact to patients. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 185
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 00380740144814), received between Nov 6, 2018 and Oct 19, 2020 — classified as 185 malfunctions.
The most frequently reported specific device problem is “Low Readings” (92 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
Device problems
- Low Readings92
- Low Test Results90
- Incorrect, Inadequate or Imprecise Result or Readings2
- Failure to Calibrate1
Patient problems
- No Known Impact Or Consequence To Patient93
- No Patient Involvement90
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 185 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED NON-ABBOTT CONTROLS SHIFTED LOW FOR FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 15625UI00 ON THE ARCHITECT I1000 SR ANALYZER. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10702540 ↗MalfunctionSep 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER OBSERVED IMPRECISION FOR FREE T3 ON A SAMPLE WHILE PROCESSING WITH THE REAGENT LOT 15383UI00 ON THE ARCHITECT I1000 SR ANALYZER. THE FOLLOWING FREE T3 DATA WAS PROVIDED ON 08/04/2020 FOR SID (B)(6); INITIAL RESULT 1.94 PG/ML, REPEAT RESULTS 2.49 PG/ML AND < 1.50 PG/ML. THE CUSTOMER USES NORMAL RANGE; 1.88-3.18 PG/ML. THE CUSTOMER ALSO PROVIDED FOLLOWING DATA FOR TSH AND FREE T4 FOR THE SAME SAMPLE (SID (B)(6)) : TSH = 0.0471 UIU/ML (NORMAL RANGE 0.35-4.94 UIU/ML) FREE T4 = 1.65 NG/DL (NORMAL RANGE 0.70 - 1.48 NG/DL). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10490747 ↗MalfunctionAug 26, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER OBSERVED IMPRECISION FOR FREE T3 ON A SAMPLE WHILE PROCESSING WITH THE REAGENT LOT 12196UI00 ON THE ARCHITECT I1000SR ANALYZER. THE CUSTOMER PROVIDED FOLLOWING DATA FOR SID (B)(6) ON (B)(6) 2020. INITIAL RESULT 4.05 PG/ML REPEAT RESULTS 3.3 PG/ML. THE FSR PERFORMED TROUBLESHOOTING, RAN QUALITY CONTROLS AND PRECISION AND ALL RECOVERED WITHIN SPECIFICATION. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10454327 ↗MalfunctionAug 26, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED RANDOX QUALITY CONTROLS OUT OF RANGE LOW FOR FREE T3 ON LOW LEVEL WHILE PROCESSING WITH THE REAGENT LOT 13120UI00 ON THE ARCHITECT I1000 SR ANALYZER. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 10453812 ↗MalfunctionAug 6, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED BIORAD QUALITY CONTROLS LOT 40380 ARE OUT OF RANGE LOW FOR FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 12196UI00 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 10375007 ↗MalfunctionAug 6, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED QUALITY CONTROLS SHIFTED LOW FOR FREE T3 WHILE PROCESSING WITH REAGENT LOT 12006UI00 ON THE ARCHITECT I1000 SR ANALYZER. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 10373692 ↗MalfunctionJul 17, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED QUALITY CONTROLS ARE RUNNING LOW FOR FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 12196UI00 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 10292124 ↗MalfunctionJul 14, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED LOW FREET3 RESULTS WHILE PROCESSING ON THE ARCHITECT I1000 ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10271551 ↗MalfunctionJun 18, 2020Low Test Results; Low Test Results
THE CUSTOMER OBSERVED INTERNAL AND EXTERNAL QUALITY CONTROLS SHIFTED LOW FOR FREE T3 WHILE PROCESSING ON THE ARCHITECT I2000SR ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10167220 ↗MalfunctionJun 18, 2020Low Test Results; Low Test Results
THE CUSTOMER OBSERVED INTERNAL AND EXTERNAL QUALITY CONTROLS SHIFTED LOW FOR FREE T3 WHILE PROCESSING ON THE ARCHITECT I2000SR ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10167198 ↗MalfunctionJun 18, 2020Low Test Results; Low Test Results
THE CUSTOMER OBSERVED INTERNAL AND EXTERNAL QUALITY CONTROLS SHIFTED LOW FOR FREE T3 WHILE PROCESSING ON THE ARCHITECT I2000SR ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10167116 ↗MalfunctionJun 8, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED BIO-RAD QUALITY CONTROLS SHIFTED DOWN FOR FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 06426UI00 ON THE ARCHITECT I1000SR ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10127841 ↗MalfunctionMar 11, 2020Low Test Results; Low Test Results
THE CUSTOMER REPORTED A FALSE DECREASED FREE T3 RESULT WHEN PROCESSING WITH THE REAGENT LOT 08328UI00 ON THE ARCHITECT I1000SR. NO SPECIFIC PATIENT INFORMATION OR DATA WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9819595 ↗MalfunctionMar 10, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED IMPRECISION ON BIO-RAD QUALITY CONTROLS FOR FREE T3(FT3) WHEN PROCESSING WITH THE REAGENT LOT 10460UI00 ON THE ARCHITECT I1000SR. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9813886 ↗MalfunctionMar 9, 2020Low Test Results; Low Test Results
THE CUSTOMER OBSERVED BIO-RAD QUALITY CONTROLS ARE OUT OF RANGE LOW AND RESULTS WERE FALSE DEPRESSED ON 2 PATIENTS FOR FREET3(FT3) WHILE PROCESSING WITH THE REAGENT LOT 06426UI00 ON THE ARCHITECT I2000SR. THE FOLLOWING PATIENT DATA WAS PROVIDED. SID (B)(6); INITIAL RESULT 1.78 PG/ML, REPEAT ON THE REFERENCE INSTRUMENT 2.53 PG/ML, SID (B)(6); INITIAL RESULT 1.85 PG/ML, REPEAT ON THE REFERENCE INSTRUMENT 2.56 PG/ML, THE CUSTOMER USES NORMAL RANGE 1.88-3.18. THE CUSTOMER STATED RESULTS ARE WITHIN RANGE WITH THE REAGENT LOT 0402IU00. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9805561 ↗MalfunctionMar 9, 2020Low Test Results; Low Test Results
THE CUSTOMER REPORTED FALSE DECREASED FREE T3 RESULTS OF <1.5 NG/ML FOR PATIENT SAMPLES AND BIO-RAD CONTROLS OUT OF RANGE LOW, WHEN PROCESSING ON THE ARCHITECT I2000. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6): INITIAL < 1.5 PG/ML, REPEAT 1.79 PG/ML, SID XXXX: INITIAL 1.55 PG/ML, REPEAT < 1.5 PG/ML, (B)(6) <1.5 PG/ML , (B)(6)<1.5 PG/ML , (B)(6) <1.5 PG/ML. SAMPLES WERE REPEATED WITH THE REAGENT LOT 08328UI00 AND OBTAINED IDENTICAL RESULTS. 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 9805481 ↗MalfunctionMar 9, 2020Low Test Results; Low Test Results
THE CUSTOMER REPORTED FALSE DECREASED FREE T3 RESULTS OF <1.5 NG/ML FOR PATIENT SAMPLES AND BIO-RAD CONTROLS OUT OF RANGE LOW, WHEN PROCESSING ON THE ARCHITECT I2000. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6): INITIAL < 1.5 PG/ML, REPEAT 1.79 PG/ML , SID XXXX: INITIAL 1.55 PG/ML, REPEAT < 1.5 PG/ML, (B)(6)<1.5 PG/ML, (B)(6) <1.5 PG/ML, (B)(6) <1.5 PG/ML. SAMPLES WERE REPEATED WITH THE REAGENT LOT 08328UI00 AND OBTAINED IDENTICAL RESULTS. 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 9805398 ↗MalfunctionFeb 28, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED NON-ABBOTT QUALITY CONTROLS SHIFTED DOWN FOR FREE T3(FT3) WHEN PROCESSING WITH THE REAGENT LOT 10460UI00 ON THE ARCHITECT I1000SR. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9771452 ↗MalfunctionFeb 27, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED QUALITY CONTROLS WERE RUNNING LOW AND IMPRECISION DURING VALIDATION FOR FREE T3(FT3) WHILE PROCESSING WITH THE REAGENT LOT 10460UI00 ON THE ARCHITECT I2000SR. FOLLOWING DATA PROVIDED FOR THE QUALITY CONTROLS. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9763410 ↗MalfunctionFeb 26, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED IMPRECISION FOR FREE T3(FT3) WHILE RUNNING ABBOTT QUALITY CONTROLS WITH REAGENT LOT 10460UI00 ON THE ARCHITECT I2000SR. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9758826 ↗MalfunctionFeb 20, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED BIO-RAD QUALITY CONTROLS, LOT 40370 ARE OUT OF RANGE LOW FOR FREE T3 (FT3) WHILE USING REAGENT LOT 06426UI00 ON THE ARCHITECT I1000SR ANALYZER. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9732617 ↗MalfunctionJan 8, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED THAT BIO-RAD QUALITY CONTROLS, LOT 40350 ARE OUT OF RANGE LOW WHILE USING FREE T3 (FT3) REAGENT LOT 06426UI00 ON THE ARCHITECT I1000 SR ANALYZER. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9563992 ↗MalfunctionDec 19, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED ARCHITECT FREE T3 (FT3) CONTROLS TRENDING LOW. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9495357 ↗MalfunctionDec 13, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED ARCHITECT FREE T3 (FT3) CONTROLS TRENDING LOW. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9467987 ↗MalfunctionDec 13, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED ARCHITECT FREE T3 (FT3) CONTROLS OUT OF RANGE LOW. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 9467142 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.