IMMULITE® 2000 Systems TG Thyroglobulin 10381647Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00630414972084), received between Apr 27, 2018 and Dec 9, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K982468); 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.

Recalls naming this device

1. Dec 7, 2022Class IIOpen, Classified

   Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples

   Z-0949-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INDICATED IMPRECISION ON LEVEL 1 (LOWER CONCENTRATION) QUALITY CONTROL SAMPLES AND OCCASION FAILED LEVEL 1 QUALITY CONTROL SAMPLES OUTSIDE OF SPECIFICATIONS ON THE IMMULITE 2000 SYSTEMS WHEN USING THYROGLOBULIN KIT LOT D434. WHEN QUALITY CONTROL RECOVERED OUTSIDE OF RANGE, PATIENT RESULTS WERE NOT GENERATED OR REPORTED. IN ALL CASES FOR QUALITY CONTROL OUTSIDE OF RANGE, ACCEPTABLE RESULTS WERE RECOVERED AFTER ASSAY ADJUSTMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FAILED QUALITY CONTROL SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950434 ↗
• MalfunctionDec 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INDICATED IMPRECISION WITH QUALITY CONTROL LEVEL 1 WHEN USING IMMULITE 2000 SYSTEMS WHEN USING THYROGLOBULIN KIT LOT D434. THERE WERE NO DISCORDANT PATIENT RESULTS PROVIDED BY THE CUSTOMER. THE CUSTOMER INDICATED THERE WAS NO IMPACT TO PATIENT TESTING, AND THEY CONTINUED TO PROCESS PATIENT SAMPLES FOR THYROGLOBULIN WITH KIT LOT D434. IT IS UNKNOWN IF THE RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FAILED QUALITY CONTROL SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950423 ↗
• MalfunctionDec 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INDICATED IMPRECISION ON LEVEL 1 QUALITY CONTROL SAMPLES AND OCCASIONAL QUALITY RESULTS RECOVERING OUTSIDE OF SPECIFICATIONS ON THE IMMULITE 2000 SYSTEMS WHEN USING THYROGLOBULIN KIT LOT: D431. THE ISSUE WAS OBSERVED ON ALL 4 IMMULITE SYSTEMS IN THE CUSTOMER'S LABORATORY. THE CUSTOMER PERFORMED A PATIENT SAMPLE CORRELATION BETWEEN D431 AND D429, AND THE RESULTS WERE ACCEPTABLE. RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FAILED QUALITY CONTROL SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950409 ↗
• MalfunctionDec 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INDICATED IMPRECISION ON QUALITY CONTROL SAMPLES ON THE IMMULITE 2000 SYSTEM WHEN USING THYROGLOBULIN KIT LOT 434. AS QUALITY CONTROL WERE IMPRECISE, PATIENT RESULTS WERE NOT GENERATED OR REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE QUALITY CONTROL IMPRECISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950401 ↗
• MalfunctionDec 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INDICATED IMPRECISION INVOLVING QUALITY CONTROL SAMPLES AND ISSUES WITH ADJUSTMENT ON THE IMMULITE 2000 SYSTEMS WHEN USING THYROGLOBULIN KIT LOT D433. THE ISSUE WAS OBSERVED ON ALL 4 IMMULITE SYSTEMS IN THE CUSTOMER'S LABORATORY. THERE WERE NO PATIENT RESULTS GENERATED OR REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FAILED QUALITY CONTROL SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950379 ↗
• MalfunctionDec 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INDICATED IMPRECISION ON QUALITY CONTROL SAMPLES ON THE IMMULITE 2000 XPI SYSTEM WHEN USING THYROGLOBULIN KIT LOT 434. AS QUALITY CONTROL WERE IMPRECISE, PATIENT RESULTS WERE NOT GENERATED OR REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE QUALITY CONTROL IMPRECISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950378 ↗
• MalfunctionApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT RESULTS WERE OBTAINED ON A PATIENT SAMPLE FOR THE THYROGLOBULIN (TG) ASSAY ON AN IMMULITE 2000 INSTRUMENT WHEN USING KIT LOT 357. THE SAMPLE WAS RUN NEAT WITH KIT LOT 353 AND THE RESULT WAS HIGH. A NEW BLOOD DRAW FROM THE SAME PATIENT WAS RUN ON THE SAME INSTRUMENT USING KIT LOT 357 AND THE RESULT WAS LOWER. THE SAMPLE WAS REPEATED AGAIN ON A DIFFERENT DATE (UNKNOWN IF IT WAS THE INITIAL SAMPLE OR THE SAMPLE FROM THE NEW BLOOD DRAW, OR ANOTHER NEW BLOOD DRAW) ON THE SAME IMMULITE 2000 INSTRUMENT AND THE RESULT WAS LOWER. THE TG KIT LOT USED TO RE-RUN THE SAMPLE WAS NOT PROVIDED. THE LOWER RESULTS WERE QUESTIONED BY THE PHYSICIAN(S). ALL THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHICH OF THE RESULTS IS THE EXPECTED RESULT ON THE PATIENT SAMPLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE DISCORDANT THYROGLOBULIN RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7469716 ↗
• MalfunctionApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT RESULTS WERE OBTAINED ON A PATIENT SAMPLE FOR THE THYROGLOBULIN (TG) ASSAY ON AN IMMULITE 2000 INSTRUMENT WHEN USING KIT LOT 357. THE SAMPLE WAS RUN NEAT WITH KIT LOT 353 AND THE RESULT WAS HIGH. A NEW BLOOD DRAW FROM THE SAME PATIENT WAS RUN ON THE SAME INSTRUMENT USING KIT LOT 357 AND THE RESULT WAS LOWER. THE SAMPLE WAS REPEATED AGAIN ON A DIFFERENT DATE (UNKNOWN IF IT WAS THE INITIAL SAMPLE OR THE SAMPLE FROM THE NEW BLOOD DRAW, OR ANOTHER NEW BLOOD DRAW) ON THE SAME IMMULITE 2000 INSTRUMENT AND THE RESULT WAS LOWER. THE TG KIT LOT USED TO RE-RUN THE SAMPLE WAS NOT PROVIDED. THE LOWER RESULTS WERE QUESTIONED BY THE PHYSICIAN(S). ALL THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHICH OF THE RESULTS IS THE EXPECTED RESULT ON THE PATIENT SAMPLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE DISCORDANT THYROGLOBULIN RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7469702 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K982468. One submission often covers many models, so check the product and lot details in each record.

• Z-0950-2023 · Dec 7, 2022 · Open, Classified
  IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized
• Z-1685-2018 · Jan 2, 2018 · Terminated
  IMMULITE 2000/IMMULITE 2000 XPi TG