Dimension Vista® Flex® reagent cartridge LIPL 10461745Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768020223), received between Sep 27, 2018 and Sep 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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 27, 2018Low Test Results; Low Test Results

  DISCORDANT FALSELY DEPRESSED LIPASE (LIPL) RESULTS WERE OBTAINED ON QC AND PATIENT SAMPLES ON THE DIMENSION VISTA 500 SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT SAMPLES WERE REPROCESSED DUE TO QC BEING OUT OF LABORATORY RANGES. HIGHER RESULTS AND WITHIN RANGE QC VALUES WERE OBTAINED ON THE SAME SAMPLES ON AN ALTERNATE DIMENSION VISTA AND ON REPROCESSING ON THE ORIGINAL DIMENSION VISTA WITH A NEW FLEX REAGENT CARTRIDGE FROM THE SAME LOT. CORRECTED PATIENT RESULTS WERE REPORTED. THERE ARE NO REPORTS OF TREATMENT CHANGE OR ADVERSE HEALTH CONSEQUENCES TO THE PATIENTS DUE TO THE DISCORDANT FALSELY DEPRESSED LIPL RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7915178 ↗