Dimension Vista® Flex® reagent cartridge E2 10489099Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768026461), received between Aug 15, 2018 and Dec 5, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High 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.

• MalfunctionDec 5, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED LOCI ESTRADIOL (E2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA® 500 INTELLIGENT LAB SYSTEM. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME INSTRUMENT, TWO ALTERNATE SIEMENS INSTRUMENTS AND ON A NON-SIEMENS SYSTEM. THE REPROCESSED RESULTS FROM THE ALTERNATE INSTRUMENTS WERE LOWER THAN THE FALSELY ELEVATED RESULT AND CONSIDERED CORRECT. THE RESULT FROM THE NON-SIEMENS SYSTEM WAS PROVIDED TO THE PHYSICIAN(S) ON A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED E2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15917259 ↗
• MalfunctionAug 15, 2018High Test Results; High Test Results

  A DISCORDANT ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED ON A PATIENT'S SAMPLE ON THE DIMENSION VISTA 1500 SYSTEM. THE SAME SAMPLE WAS TESTED BY TWO ALTERNATE NON-SIEMENS METHODOLOGIES AND LOWER RESULTS WERE OBTAINED CONSISTENT WITH PHYSICIAN EXPECTATIONS. THERE ARE NO REPORTS OF TREATMENT CHANGE OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED E2 RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7787093 ↗