Dimension® Flex® reagent cartridge VALP 10444943Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842768005718), received between Sep 6, 2017 and Sep 6, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED VALPROIC ACID (VALP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED VALP RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6845712 ↗
• MalfunctionSep 6, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED VALPROIC ACID (VALP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED VALP RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6845705 ↗
• MalfunctionSep 6, 2017Low Test Results; Low Test Results

  A DISCORDANT DEPRESSED VALPROIC ACID (VALP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED VALP RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6845696 ↗