Atellica IM FT3 10995584Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Free T3 (FT3) Atellica IM - RGT 300T · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00630414599083), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2023Low Test Results; Low Test Results
THE CUSTOMER DOES NOT ROUTINELY RUN THE FREE TRIIODOTHYRONINE (FT3) TEST ON THE ATELLICA IM, HOWEVER, THE CUSTOMER OBSERVED RESULTS FROM TWO PATIENT SAMPLES WERE DEPRESSED COMPARED TO TESTING ON THE ADVIA CENTAUR FT3 AND AN ALTERNATE METHOD FT3 ASSAY. THE ATELLICA IM FT3 RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED FT3 PATIENT RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17556943 ↗
Other RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE devices
- ARCHITECT 07K6327Abbott Ireland · RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE185 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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