Dimension Vista® Flex® reagent cartridge PRL 10488398Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768026454), received between Jun 4, 2018 and Jun 4, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Or Inadequate 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.

• MalfunctionJun 4, 2018Incorrect Or Inadequate Test Results

  A PROLACTIN (PRL) RESULT WAS REPORTED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT AND QUESTIONED BY THE PHYSICIAN AS THE RESULT WAS LOWER THAN EXPECTED. THE SAME SAMPLE WAS REPEATED THE FOLLOWING DAY CONFIRMING THE INITIAL RESULT. CUSTOMER REPORTED PERFORMING SERIAL DILUTIONS AFTER THE PHYSICIAN QUESTIONED THE INITIAL RESULT. DILUTION FACTORS WERE ENTERED IN THE INSTRUMENT BUT NO MANUAL DILUTIONS WERE PERFORMED ON THE SAMPLE PRIOR TO TESTING WHICH PRODUCED HIGHER RESULTS. A NEW SAMPLE WAS DRAWN AND SERIAL DILUTIONS WERE PERFORMED CORRECTLY AT A LATER DATE. THE SERIAL DILUTIONS RECOVERED AS EXPECTED WHEN COMPARED TO THE INITIAL PATIENT SAMPLE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PRL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7567156 ↗