Dimension Vista® MULTI 1 SDIL 10469971Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842768030314), received between Mar 26, 2018 and Mar 28, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2018High Test Results; High Test Results

  A FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED ON A CAP SURVEY SAMPLE ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULT WAS SCORED AS UNACCEPTABLE BY THE CAP. THERE IS NO INDICATION THAT PATIENT SAMPLES HAVE BEEN AFFECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7376904 ↗
• MalfunctionMar 26, 2018High Test Results; High Test Results

  A FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED ON A CAP SURVEY SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULT WAS SCORED AS UNACCEPTABLE BY THE CAP. THE CUSTOMER STATED THAT NO PATIENT SAMPLES HAVE BEEN AFFECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7371142 ↗
• MalfunctionMar 26, 2018High Test Results; High Test Results

  DISCORDANT ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE ORIGINAL SAMPLES WHICH HAD BEEN TESTED BY AUTO-DILUTION WERE REPEATED BY MANUAL DILUTION AND LOWER RESULTS WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AUTO-DILUTION RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7371141 ↗
• MalfunctionMar 26, 2018High Test Results; High Test Results

  DISCORDANT ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE ORIGINAL SAMPLES WHICH HAD BEEN TESTED BY AUTO-DILUTION WERE REPEATED BY MANUAL DILUTION AND LOWER RESULTS WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AUTO-DILUTION RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7371138 ↗
• MalfunctionMar 26, 2018High Test Results; High Test Results

  DISCORDANT ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 INSTRUMENT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE ORIGINAL SAMPLES WHICH HAD BEEN TESTED BY AUTO-DILUTION WERE REPEATED BY MANUAL DILUTION AND LOWER RESULTS WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AUTO-DILUTION RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7371136 ↗
• MalfunctionMar 26, 2018High Test Results; High Test Results

  DISCORDANT ELEVATED ESTRADIOL (E2) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE ORIGINAL SAMPLES WHICH HAD BEEN TESTED BY AUTO-DILUTION WERE REPEATED BY MANUAL DILUTION AND LOWER RESULTS WERE OBTAINED. CORRECTED RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AUTO-DILUTION RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7371133 ↗