ARCHITECT 7K63-01Recalls & reported problems
Abbott Ireland · ARCHITECT Free T3 Calibrators · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740014254), received between Nov 20, 2018 and Nov 20, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Readings” (1 report).
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 Readings1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2018Low Readings; Low Readings
THE CUSTOMER REPORTED CONTROLS SHIFTED LOW WHILE USING THE ARCHITECT FREE T3 ASSAY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8090893 ↗
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- 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.