IMMULITE® 2000 Systems IGFBP-3 10381447Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414966113), received between Jul 2, 2024 and Aug 14, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252605 ↗
• MalfunctionJan 7, 2026Low Test Results

  THE CUSTOMER PERFORMED A ROUTINE RESET FOR THE IGFBP-3 (INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3) ASSAY, MEASURED ON THE IMMULITE 2000 XPI ANALYZER #O6345, AFTER THE MOVING MEDIAN REGISTERED IN THE CUSTOMER'S SYSTEM WAS REJECTED. THE MOVING MEDIAN IS USED AS A PATIENT-BASED QUALITY CONTROL. FOR EVERY 30 PATIENT RESULTS, THE SYSTEM GENERATES A MEDIAN VALUE, WHICH IS PLOTTED ON A MONITORING GRAPH. FOR THIS ASSAY, THE MEDIAN REGISTERED ON THE GRAPH IS 4.97, WITH A STANDARD DEVIATION (SD) OF 0.27. IF THE MOVING MEDIAN VALUE EXCEEDS THE LIMITS ESTABLISHED BY THE 1X 3SD OR 2X 2SD REJECTION RULES, THE CUSTOMER PERFORMS AN EVALUATION OF THE PREVIOUS ROUTINE. IN THIS CASE, THE PREVIOUS ROUTINE WAS EVALUATED AND DISCREPANCIES IN RESULTS WERE IDENTIFIED IN PATIENT SAMPLES. THE PATIENT SAMPLES WERE REPEATED ON THE SAME ANALYZER THE FOLLOWING DAY. IT IS UNKNOWN WHETHER A DIFFERENT REAGENT WEDGE/BEAD WAS USED FOR THE REPEAT TESTING ON THE SAME ANALYZER. THE INITIAL RESULTS FOR THE DISCORDANT PATIENT SAMPLES WERE REPORTED AND WERE NOT QUESTIONED BY THE PHYSICIAN(S). THE LABORATORY DID NOT SEND CORRECTED RESULTS FOR THESE DISCORDANT PATIENT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988654 ↗
• MalfunctionJul 2, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT FOLLOWING THE OBSERVATIONS OF A NEGATIVE BIAS WITH IGFBP-3 QUALITY CONTROL (QC) RESULTS AND FALSELY DEPRESSED IGFBP-3 PATIENT RESULTS INCONSISTENT WITH PREVIOUS RESULTS AND WITH THE PROFILE OF RESULTS OBTAINED IN THE LABORATORY, PREVIOUSLY TESTED PATIENT SAMPLES WERE REPEATED WITH THE IGFBP-3 ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULTS HAD BEEN REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE INITIAL RESULTS WERE FALSELY DEPRESSED IN COMPARISON TO THE REPEAT RESULTS. FOR THREE OF THE PATIENT SAMPLES, THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). FOR FOURTEEN OF THE PATIENT SAMPLES, THE LABORATORY'S MEDICAL STAFF CHOSE NOT TO RECTIFY THE RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED IGFBP-3 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661350 ↗