Valproic Acid 5108438190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630999385), received between Feb 6, 2023 and Jul 15, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K060690); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2024Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ONLINE TDM VALPROIC ACID (VALP2) ASSAY ON A COBAS 8000 COBAS C502 MODULE. INITIAL RESULT: <5 MG/L. THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED A REPEAT OF THE SAMPLE SINCE HE SUSPECTED AN INTENTIONAL DRUG INTOXICATION. REPEAT RESULT: 974 MG/L (AFTER DILUTION 1:10).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741124 ↗
• MalfunctionFeb 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR 10 PATIENT SAMPLES TESTED FOR ONLINE TDM VALPROIC ACID (VALP2) ON A COBAS 8000 C 502 MODULE. FOR ALL 10 PATIENT SAMPLES, THE INITIAL RESULT WAS 0.1 UG/ML WITH A DATA FLAG. WHEN THE SAMPLES WERE REPEATED, THE RESULTS WERE "MUCH HIGHER." THE CUSTOMER PROVIDED SPECIFIC RESULTS FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 0.1 UG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 74.9 UG/ML. THE QUESTIONABLE LOW RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE VALP2 REAGENT LOT NUMBER WAS 63608501 WITH AN EXPIRATION DATE OF 30-NOV-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16306734 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060690. One submission often covers many models, so check the product and lot details in each record.

• Z-0920-2007 · Apr 30, 2007 · Terminated
  Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.