IMMULITE® 2000 Systems VAL Valproic Acid 10381544Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414962290), received between Jul 1, 2024 and Jul 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (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.

• MalfunctionJul 1, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCORDANT HIGH VALPROIC ACID RESULTS WERE OBTAINED ON EIGHT PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S), EXCEPT IN THE CASE WHERE A REPEAT WAS NOT DONE (SAMPLE 02). SEVEN OF THE EIGHT SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE REPEATED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PHYSICIAN(S) DID NOT QUESTION THE RESULTS WHICH WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED VALPROIC ACID RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19646619 ↗