Valproic Acid 4491041190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630998913), received between Nov 15, 2022 and Nov 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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. 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.

• MalfunctionNov 3, 2025Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ONLINE TDM VALPROIC ACID RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 4.2 G/ML. THE RESULT WAS QUESTIONED BY THE PHYSICIAN, AND THE SAMPLE WAS REPEATED. THE REPEATED RESULTS WERE 184.3 G/ML AND 109.5 G/ML. A DILUTION WAS PERFORMED, AND THE RESULT WAS 219 G/ML. THIS RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER INDICATED THAT THE SAMPLE QUALITY WAS IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453205 ↗
• MalfunctionMay 6, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ONLINE TDM VALPROIC ACID (VALP2) ASSAY ON A COBAS 6000 C501 MODULE. INITIAL RESULT: 0.9 UG/ML (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 88.4 UG/ML. THE 2ND REPEAT RESULT MATCHED THE 1ST REPEAT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967140 ↗
• MalfunctionNov 15, 2022Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LOW VALPROIC ACID (VALP2) RESULT FROM THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 0.8 UG/ML WITH A DATA FLAG AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE 30.1 UG/ML AND 45.4 UG/ML. THE REPEAT RESULTS ON 27-OCT-2022 WERE 51.1 UG/ML AND 45.2 UG/ML. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798177 ↗

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.