IMMULITE® 2000 Systems FT3 Free T3 10381675Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414961361), received between Aug 8, 2017 and Jun 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K974634); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED THE OBSERVATION OF NON-REPRODUCIBLE RESULTS WHEN USING FT3 LOT 125 ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE INITIAL IMMULITE 2000 XPI INSTRUMENT USING FT3 REAGENT LOT 127 AND THE REPEAT RESULT WAS HIGHER THAN THE INITIAL RESULT. IT IS UNKNOWN WHICH RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NON-REPRODUCIBLE FT3 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197248 ↗
• MalfunctionAug 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER OBTAINED DISCORDANT FREE TRIIODOTHYRONINE (FT3) RESULTS ON PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT, WHILE USING KIT LOT 803. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, MATCHING CLINICAL PICTURE OF THE PATIENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT FT3 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6774738 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K974634. One submission often covers many models, so check the product and lot details in each record.

• Z-0867-2014 · Aug 27, 2013 · Terminated
  T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit
• Z-0868-2014 · Aug 27, 2013 · Terminated
  T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit f