IMMULITE® 2000 Systems T3 Total T3 10381654Recalls & reported problems
Siemens Healthcare Diagnostics Products Ltd · T3 Total - IMMULITE - RGT - 200 Tests · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00630414968599), received between Feb 21, 2018 and Feb 21, 2018 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Ingredient or Reagent Problem8
Patient problems
- No Known Impact Or Consequence To Patient8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THE CUSTOMER HAS INFORMED SIEMENS THAT THEY HAVE OBTAINED LOW RESULTS ON PATIENT SAMPLES FOR THE TOTAL TRIIODOTHYRONINE (T3) ASSAY ON AN IMMULITE 2000 XPI SYSTEM WHEN USING KIT LOT 359. IT IS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW RESULTS OBTAINED FOR TOTAL T3.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7286432 ↗MalfunctionFeb 21, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THE CUSTOMER HAS INFORMED SIEMENS THAT THEY HAVE OBTAINED LOW RESULTS ON PATIENT SAMPLES FOR THE TOTAL TRIIODOTHYRONINE (T3) ASSAY ON AN IMMULITE 2000 XPI SYSTEM WHEN USING KIT LOT 356. IT IS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW RESULTS OBTAINED FOR TOTAL T3.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7286429 ↗MalfunctionFeb 21, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THE CUSTOMER HAS INFORMED SIEMENS THAT THEY HAVE OBTAINED LOW RESULTS ON PATIENT SAMPLES FOR THE TOTAL TRIIODOTHYRONINE (T3) ASSAY ON AN IMMULITE 2000 XPI SYSTEM WHEN USING KIT LOT 349. IT IS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW RESULTS OBTAINED FOR TOTAL T3.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7286425 ↗MalfunctionFeb 21, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THE CUSTOMER HAS INFORMED SIEMENS THAT THEY HAVE OBTAINED LOW RESULTS ON PATIENT SAMPLES FOR THE TOTAL TRIIODOTHYRONINE (T3) ASSAY ON AN IMMULITE 2000 XPI SYSTEM WHEN USING KIT LOT 352. IT IS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW RESULTS OBTAINED FOR TOTAL T3.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7286423 ↗MalfunctionFeb 21, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THE CUSTOMER HAS INFORMED SIEMENS THAT THEY HAVE OBTAINED LOW RESULTS ON PATIENT SAMPLES FOR THE TOTAL TRIIODOTHYRONINE (T3) ASSAY ON AN IMMULITE 2000 XPI SYSTEM WHEN USING KIT LOT 354. IT IS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW RESULTS OBTAINED FOR TOTAL T3.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7286412 ↗MalfunctionFeb 21, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THE CUSTOMER HAS INFORMED SIEMENS THAT THEY HAVE OBTAINED LOW RESULTS ON PATIENT SAMPLES FOR THE TOTAL TRIIODOTHYRONINE (T3) ASSAY ON AN IMMULITE 2000 XPI SYSTEM WHEN USING KIT LOT 350. IT IS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW RESULTS OBTAINED FOR TOTAL T3.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7286408 ↗MalfunctionFeb 21, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THE CUSTOMER HAS INFORMED SIEMENS THAT THEY HAVE OBTAINED LOW RESULTS ON PATIENT SAMPLES FOR THE TOTAL TRIIODOTHYRONINE (T3) ASSAY ON AN IMMULITE 2000 XPI SYSTEM WHEN USING KIT LOT 347. IT IS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW RESULTS OBTAINED FOR TOTAL T3.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7286407 ↗MalfunctionFeb 21, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THE CUSTOMER HAS INFORMED SIEMENS THAT THEY HAVE OBTAINED LOW RESULTS ON PATIENT SAMPLES FOR THE TOTAL TRIIODOTHYRONINE (T3) ASSAY ON AN IMMULITE 2000 XPI SYSTEM WHEN USING KIT LOT 346. IT IS UNKNOWN IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW RESULTS OBTAINED FOR TOTAL T3.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7286397 ↗
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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