ARCHITECT 07K6437Recalls & reported problems
Abbott Ireland · ARCHITECT Total T3 Reagent Kit (500T) · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740144883), received between Nov 26, 2018 and Apr 9, 2019 — classified as 5 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
Patient problems
- No Patient Involvement5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2019Low Readings; Low Readings
THE CUSTOMER OBSERVED IMPRECISE ARCHITECT TOTAL 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 8496866 ↗MalfunctionApr 9, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED CONTROLS SHIFTING DOWN FOR ARCHITECT TOTAL T3 (TT3). THERE WERE NO ACTUAL PATIENT RESULTS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Patient Involvement
MAUDE report 8495985 ↗MalfunctionDec 18, 2018Low Readings; Low Readings
CUSTOMER REPORTED ARCHITECT TOTAL T3 CONTROLS ARE TRENDING LOW. THERE WERE NO PATIENT RESULTS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8175226 ↗MalfunctionDec 6, 2018Low Readings; Low Readings
THE CUSTOMER REPORTED TECHNOPATH HIGH QC SHIFTED LOW, WHILE USING THE ARCHITECT TOTAL T3 REAGENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8137794 ↗MalfunctionNov 26, 2018Low Readings; Low Readings
THE CUSTOMER REPORTED IMPRECISE CONTROL RESULTS WHILE USING THE ARCHITECT TOTAL T3, ARCHITECT ANTI- TG, AND ARCHITECT ANTI-TPO REAGENTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8101585 ↗
Other RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE devices
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- Elecsys FT3 III 09005811190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE134 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.