ADVIA Centaur® FT3 10310318Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Free T3 - CENTAUR - RGT - 250 tests · Class 2
Data updated Oct 16, 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 00630414207537), received between Mar 9, 2018 and Mar 9, 2018 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FALSE LOW ADVIA CENTAUR XP FT3 RESULTS WERE OBTAINED BY THE CUSTOMER ON A REAGENT READYPACK AND CONSIDERED DISCORDANT WHEN COMPARED TO HIGHER RESULTS ON ANOTHER REAGENT READYPACK THAT HAS ACCEPTABLE QUALITY CONTROL RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW CENTAUR XP FT3 RESULTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7328423 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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