Dimension Vista® Flex® reagent cartridge DBIL 10445152Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768015649), received between Jul 31, 2019 and Jul 31, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “High 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.

• MalfunctionJul 31, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED DIRECT BILIRUBIN (DBI) RESULTS WERE OBTAINED ON PEDIATRIC PATIENT SAMPLES ON A DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. NEW SAMPLES WERE PROCESSED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND LOWER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. ONE PATIENT (SAMPLE ID (B)(6)) WAS TREATED FOR THE ELEVATED DBI RESULT BY HAVING ADDITIONAL BLOOD DRAWS, BEING FED A SPECIAL FORMULA INSTEAD OF BREASTMILK AND HAVING A LIVER ULTRASOUND WHICH GAVE A NORMAL RESULT. THERE WERE NO ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED DBI RESULTS OR DUE TO THE TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8845546 ↗