Elecsys T3 09007725190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
All models of Elecsys T3 (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336171646), received between Oct 23, 2025 and Jan 26, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Non Reproducible Results
1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T3 RESULTS FOR ONE PATIENT FROM THE COBAS E411 RACK ANALYZER. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24183981 ↗MalfunctionOct 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T3 RESULTS FOR ONE PATIENT FROM THE COBAS 6000 E601 MODULE. 2. PATIENT AGE RANGE: 53 YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: MALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23369194 ↗
Other RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE devices
- ARCHITECT 07K6327Abbott Ireland · RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE185 reports
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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 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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