ARCHITECT 7K63-25Recalls & reported problems
Abbott Ireland · ARCHITECT Free T3 Reagent Kit (100T) · Class 2
Quick summary
This Abbott ARCHITECT free triiodothyronine reagent kit has 108 malfunction reports, with no deaths and no injuries. Most reports describe quality controls or test results reading low or erratically, and a few describe imprecise results on samples. Many reports state that patient care was not affected. 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
- 108
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00380740014285), received between Nov 5, 2018 and Nov 16, 2021 — classified as 108 malfunctions.
The most frequently reported specific device problem is “Low Readings” (79 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 Readings79
- Low Test Results23
- Incorrect, Inadequate or Imprecise Result or Readings7
Patient problems
- No Patient Involvement81
- No Known Impact Or Consequence To Patient20
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER OBSERVED TECHNOPATH QUALITY CONTROLS ARE OUT OF RANGE LOW FOR FREE T3 (FT3) WHILE PROCESSING WITH THE REAGENT LOT 25157UD00 ON THE ARCHITECT ANALYZER. THERE WAS NO PATIENT INVOLVEMENT AND NO IMPACT TO THE PATIENT RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12823383 ↗MalfunctionOct 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER OBSERVED CALIBRATION OUTLIERS FOR THE ARCHITECT FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 25157UD00. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12579444 ↗MalfunctionJul 29, 2021Low Readings; Low Readings
THE CUSTOMER OBSERVED BIO RAD QUALITY CONTROLS WERE OUT OF RANGE LOW FOR ARCHITECT FREE T3(FT3) WHILE PROCESSING WITH THE REAGENT LOT 25157UD00. NO DISCREPANT PATIENT RESULTS WERE GENERATED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12245685 ↗MalfunctionJun 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER OBSERVED IMPRECISE ARCHITECT I FREE T3 (FT3) RESULTS ON ONE PATIENT. THE CUSTOMER PROVIDED FOLLOWING DATA. (B)(6). 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 Clinical Signs, Symptoms or Conditions
MAUDE report 11912271 ↗MalfunctionMay 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER OBSERVED IMPRECISION FOR FREE T3 (FT3) ON THE CAP SURVEY SAMPLES WHILE PROCESSING WITH THE REAGENT LOT 21081UI00 ON THE ARCHITECT I1000SR ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11886543 ↗MalfunctionMar 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results
THE CUSTOMER OBSERVED LOW OR ERRATIC RESULTS FOR ARCHITECT FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 21081UI00. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11590027 ↗MalfunctionFeb 4, 2021Low Readings; Low Readings
THE CUSTOMER OBSERVED NON-ABBOTT ARCHITECT FREE T3 (FT3) QUALITY CONTROLS OUT OF RANGE LOW WHILE PROCESSING WITH THE REAGENT LOT 21081UI00 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11282404 ↗MalfunctionDec 14, 2020Low Test Results; Low Test Results
THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT FREE T3 (FT3) RESULTS ON MULTIPLE PATIENTS WITH THE REAGENT LOT 14456UI00. RESULTS PROVIDED: (B)(6) 2020. SID ARCHITECT SIEMENS ATELLICA: (B)(6). REFERENCE RANGE FROM 1.71 TO 3.71 PG/ML ON ABBOTT ARCHITECT; REFERENCE RANGE FOR SIEMENS ATELLICA SYSTEM IS 2.3 TO 4.2 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11004221 ↗MalfunctionDec 5, 2020Low Test Results; Low Test Results
THE CUSTOMER STATED THAT FALSELY DECREASED ARCHITECT FREE T3 VALUES <1 PG/ML WERE OBSERVED FOR PATIENT SAMPLES THAT TESTED NORMAL UPON RETESTING. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE CUSTOMER PROVIDED FOLLOWING DATA. DATE SID VALUE REPEAT VALUE: (B)(6) -2020 (B)(6) <1 1.33, (B)(6) -2020 (B)(6) <1 1.31, (B)(6) -2020 (B)(6) <1 1.31, (B)(6) -2020 (B)(6) <1 1.81, (B)(6) -2020 (B)(6) <1 2.02, (B)(6) -2020 (B)(6) <1 1.64, (B)(6) -2020 (B)(6) <1 1.74, (B)(6) -2020 (B)(6) <1 1.75, (B)(6) -2020 (B)(6) <1 1.6.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10953185 ↗MalfunctionNov 24, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED TECHNOPATH QUALITY CONTROLS SHIFTED DOWN FOR ARCHITECT FREE WHILE PROCESSING WITH THE REAGENT LOT 14456UI00. THERE WAS NO SPECIFIC DATA PROVIDED AND NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Patient Involvement
MAUDE report 10897680 ↗MalfunctionNov 13, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED NON-ABBOTT QUALITY CONTROLS FOR ARCHITECT TOTAL T3 (TT3) SHIFTED DOWN WHILE PROCESSING WITH THE REAGENT LOT 14456UI00. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 10839766 ↗MalfunctionNov 12, 2020Low Test Results; Low Test Results
THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT FREE T3 (FT3) RESULTS ON FOUR PATIENTS. RESULTS PROVIDED: 29OCT2020 SID UHID: (B)(4) = < 1.00 / 1.30 PG/ML; SID (B)(4) = < 1.00 / 1.61 PG/ML; SID (B)(4) = < 1.00 / 1.68 PG/ML; SID (B)(4) = < 1.00 / 1.52 PG/ML. FT3 NORMAL RANGE: 1.71 ¿ 3.71 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10832805 ↗MalfunctionNov 5, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED NON- ABBOTT QUALITY CONTROLS SHIFTED LOW FOR ARCHITECT FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 14456UI00. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 10791334 ↗MalfunctionNov 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER OBSERVED QUALITY CONTROLS SHIFTED LOW FOR HIGH LEVEL FOR ARCHITECT FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 14456UI00 THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 10770330 ↗MalfunctionOct 27, 2020Low Test Results; Low Test Results
THE CUSTOMER REPORTED FALSELY DECREASED ARCHITECT FREE T3 (FT3) RESULTS ON MULTIPLE PATIENTS. EXAMPLE RESULTS PROVIDED: NORMAL RANGE: 3.8-6.8 PMOL/L. ARCHITECT REFERENCE LAB 2.67, 3.6; 2.96, 3.6; 2.64, 3.2; 3.05, 3.8; 2.99, 3.6; 3.0, 3.3; 3.07, 4.9. ADDITIONALLY, A RESULT OF 2.74 PMOL/L WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10743502 ↗MalfunctionOct 18, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED NON-ABBOTT CONTROLS SHIFTED LOW FOR FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 14456UI00 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 10694730 ↗MalfunctionOct 16, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED QUALITY CONTROLS SHIFTED LOW FOR FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 14456UI00 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 10693215 ↗MalfunctionSep 23, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED THERMO-FISCHER QUALITY CONTROLS OUT OF RANGE LOW FOR FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 14456UI00 ON THE ARCHITECT I1000SR ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 10576953 ↗MalfunctionSep 20, 2020Low Test Results; Low Test Results
THE CUSTOMER OBSERVED FALSELY DEPRESSED PATIENT SAMPLES AND QUALITY CONTROLS FOR FREE T3 WHILE CORRELATION BEING DONE ON THE ARCHITECT I2000SR ANALYZER USING REAGENT LOT 14456UI00. THE CUSTOMER PROVIDED FOLLOWING DATA FOR THE PATIENT SAMPLES. PATIENT 1: RESULTS WITH NEW LOT OF REAGENT 2.6, RESULTS WITH OLD LOT OF REAGENT 3.4. PATIENT 2: RESULTS WITH NEW LOT OF REAGENT 4.6, RESULTS WITH OLD LOT OF REAGENT 5.2. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 10558269 ↗MalfunctionSep 20, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED TECHNO PATH QUALITY CONTROLS OUT OF RANGE LOW FOR FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 14456UI00 ON THE ARCHITECT I1000SR ANALYZER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 10558225 ↗MalfunctionAug 28, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED QUALITY CONTROLS ARE RUNNING OUT OR RANGE LOW AND ERRATIC FOR FREE T3 WHILE PROCESSING 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 10468522 ↗MalfunctionAug 28, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED QUALITY CONTROLS ARE RUNNING OUT OR RANGE LOW AND ERRATIC FOR FREE T3 WHILE PROCESSING 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 10468499 ↗MalfunctionAug 26, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED TECHNOPATH QUALITY CONTROLS, LOT 32601190 ARE OUT OF RANGE LOW FOR FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 14456UI00 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 10454478 ↗MalfunctionAug 6, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED BIORAD QUALITY CONTROLS, LOT 40380, 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 10375051 ↗MalfunctionJul 14, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED TF MAS QUALITY CONTROLS ARE OUT OF RANGE LOW FOR FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 09189UI00 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 10273196 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.