Dimension® Flex® reagent cartridge VANC 10444929Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768005763), received between Aug 18, 2020 and Mar 9, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY DEPRESSED VANCOMYCIN (VANC) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAMPLES WERE REPEATED ON SAME DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE REPEAT RESULTS RECOVERED HIGHER AND WERE CONSIDERED CORRECT. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DEPRESSED VANC RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543172 ↗
• MalfunctionAug 18, 2020High Test Results; Low Test Results; High Test Results; Low Test Results

  DISCORDANT, FALSELY ELEVATED AND FALSELY DEPRESSED VANCOMYCIN (VANC) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAME SAMPLE WAS REPROCESSED THE SAME DAY WITH AN ALTERNATE UNKNOWN INSTRUMENT AND LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND REPORTED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED VANC RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423011 ↗