Valproic Acid 20737933322Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630915958), received between Sep 19, 2018 and Sep 19, 2018 — 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.

• MalfunctionSep 19, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT TESTED FOR VALP VALPROIC ACID (VALP) ON A COBAS INTEGRA 400 PLUS. THE INITIAL RESULT WAS 345 UG/ML. THE SAMPLE WAS DILUTED 1:2 AND THE RESULT WAS 344 UG/ML. A NEW SAMPLE WAS OBTAINED ON (B)(6) 2018 AND THE RESULT WAS 160 UG/ML. THESE RESULTS WERE BELIEVED TO BE TOO HIGH. THE CUSTOMER SUSPECTS AN INTERFERENCE. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE INTEGRA 400 PLUS SERIAL NUMBER WAS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7890647 ↗