Dimension Vista® Flex® reagent cartridge AFP 10463378Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768019937), received between Apr 11, 2019 and Apr 11, 2019 — 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.

• MalfunctionApr 11, 2019Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED ALPHA-FETOPROTEIN (AFP) RESULT WAS OBTAINED ON A PATIENT'S SAMPLES ON THE DIMENSION VISTA 1500 SYSTEM S/N (B)(4). THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED AFP RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8506100 ↗
• MalfunctionApr 11, 2019Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED ALPHA-FETOPROTEIN (AFP) RESULT WAS OBTAINED ON A PATIENT'S SAMPLES ON THE DIMENSION VISTA 1500 SYSTEM S/N (B)(4). THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS ON THE UNDILUTED SAMPLES. THE SAME SAMPLE WAS REPROCESSED ON THE SAME INSTRUMENT WITH DILUTIONS AND HIGHER RESULTS WERE OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED AFP RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8506099 ↗