ARCHITECT 07K6332Recalls & reported problems
Abbott Ireland · ARCHITECT Free T3 Reagent Kit (2000T) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380740144821), received between Nov 20, 2018 and Apr 8, 2020 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Low Readings” (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
Device problems
- Low Readings5
- Low Test Results1
Patient problems
- No Patient Involvement5
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2020Low Readings; Low Readings
THE CUSTOMER OBSERVED IMPRECISION WITH ABBOTT QUALITY CONTROLS FOR FREE T3 WHILE PROCESSING WITH THE REAGENT LOT 12925UI00 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 9934405 ↗MalfunctionDec 9, 2019Low Readings; Low Readings
THE CUSTOMER OBSERVED ARCHITECT FREE 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 9437765 ↗MalfunctionJan 23, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED IMPRECISE ARCHITECT FREE 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 8270345 ↗MalfunctionDec 27, 2018Low Test Results; Low Test Results
CUSTOMER REPORTED FALSELY DECREASED ARCHITECT FREE T3 (FT3) RESULTS ON ONE PATIENT. AFTER RECEIPT OF FA12OCT2018A, THE CUSTOMER FOLLOWED THE PRODUCT CORRECTION LETTER INSTRUCTIONS WITHOUT IMPROVEMENT TO THE FT3. THERE WERE NO DISCREPANT PATIENT RESULTS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8199772 ↗MalfunctionNov 21, 2018Low Readings; Low Readings
THE CUSTOMER REPORTED CONTROLS SHIFTED LOW WHILE USING THE ARCHITECT FREE T3 REAGENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8094345 ↗MalfunctionNov 20, 2018Low Readings; Low Readings
THE CUSTOMER REPORTED THAT THE FALSE DECREASED TECHNOPATH CONTROLS WHILE USING THE ARCHITECT FREE T3 REAGENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8091338 ↗
Other RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE devices
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- ARCHITECT 7K64-25Abbott Ireland · RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE130 reports
- Elecsys FT3 III 07027362190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE111 reports
- Access Free T3 A13422Beckman Coulter, Inc. · Radioimmunoassay, Total Triiodothyronine1 recall7 reports
- VITROS 1315589Ortho Clinical Diagnostics · RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE1 recall0 reports
- Elecsys FT3 III 09005803190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE35 reports
- ARCHITECT 07K6427Abbott Ireland · RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE32 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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