IMMULITE® 2000 Systems IGF-1 10381448Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414961538), received between Jun 27, 2017 and Jun 27, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2017Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem; Labelling, Instructions for Use or Training Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER OBTAINED A DISCORDANT, FALSELY LOW INSULIN-LIKE GROWTH FACTOR I (IGF-1) RESULT ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT, WHEN USING REAGENT KIT LOT 113. THE SAMPLE WAS REPEATED ON AN ANOTHER IMMULITE INSTRUMENT AND THE RESULT MATCHED THE INITIAL RESULT. THE SAMPLE WAS TESTED ON AN ALTERNATE PLATFORM, AND THE RESULT WAS HIGHER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE CORRECTED RESULT FROM THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW IGF-1 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6669657 ↗