Dimension Vista® CTNI CAL 10445197Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842768016738), received between May 24, 2019 and May 24, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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.

• MalfunctionMay 24, 2019Low Test Results; Low Test Results

  DISCORDANT DEPRESSED CARDIAC TROPONIN I (CTNI) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION VISTA 1500 SYSTEM AFTER CALIBRATION WITH THE CARDIAC TROPONIN CALIBRATOR (CTNI CAL). THE LOW RESULTS WERE REPORTED TO THE PHYSICIAN(S). AFTER RECALIBRATION, THE SAMPLES WERE REPROCESSED ON THE SAME SYSTEM AND HIGHER RESULTS WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF TREATMENT CHANGES OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED CTNI RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641504 ↗