Syva® Emit® 2000 Valproic Acid Assay 10445312Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768000942), received between Dec 21, 2021 and Dec 21, 2021 — 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.

• MalfunctionDec 21, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED VALPROIC ACID PATIENT SAMPLE RESULT WAS OBTAINED ON VIVA E SYSTEM. THE DISCORDANT PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME PATIENT SAMPLE WAS REPROCESSED ON THE ORIGINAL SYSTEM, AND A LOWER VALPROIC ACID RESULT WAS OBTAINED. THE LOWER REPROCESSED RESULT WAS CONSIDERED CORRECT AND REPORTED. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13054771 ↗