ARCHITECT 7K63-35Recalls & reported problems
Abbott Ireland · ARCHITECT Free T3 Reagent Kit (500T) · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740105921), received between Jan 29, 2019 and Jun 3, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Low Readings” (3 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 Readings3
Patient problems
- No Patient Involvement3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 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 8662878 ↗MalfunctionMar 18, 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 8427954 ↗MalfunctionJan 29, 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 8285161 ↗
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- 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.