Skip to content

Xevo 186005833IVDRecalls & reported problems

Waters Technologies Corporation · Xevo TQD IVD · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816776020162), received between Mar 2, 2022 and Mar 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Missing 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Missing Test Results1
  • Output Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 2, 2022Output Problem; Missing Test Results; Output Problem; Missing Test Results

    THE CUSTOMER REPORTS THAT THE LAST COMPOUNDS IN THE LAST SAMPLE OF A BATCH SOMETIMES DOES NOT SHOW THE RESULTS PROPERLY WHEN USING AUTO REFRESH DUE TO A RACE CONDITION IN THE CODE. THE NEOLYNX. EXE PROGRAM RUNS AFTER EACH SAMPLE FINISHES ACQUIRING AND PROCESSES EACH INJECTION. THE CUSTOMER STARTS THEIR RUN, ANALYSES THE RESULTS AS ACQUIRED BY OPENING THE BROWSER & CHECKING INTENSITIES, THEN LEAVES THE BROWSER OPEN WITH AUTO-REFRESH ENABLED. WITH THE CUSTOMER'S BROWSER SET TO AUTO-REFRESH, NEOLYNX SENDS THE RESULTS TO THE BROWSER AS IT PROCESSES. A VULNERABILITY IN THE SOFTWARE MAY CAUSE NEOLYNX. EXE TO TELL THE BROWSER SOFTWARE TO REFRESH ITS DISPLAY BEFORE ALL THE DATA HAS FINISHED WRITING TO THE DISK. WHEN THIS HAPPENS, THE LAST RESULT IS INCOMPLETE IN THE BROWSER DISPLAY (BUT NOT IN THE RESULT FILE - NRF). THE SPECTRUM WINDOW IS NOT COMPLETELY LOADED, LOOKS BLANK AND THE FINAL CHANNELS OF THE LAST FUNCTION CAN BE MISSING. AT THE END OF THE RUN, THE CUSTOMER CHECKS FOR ERROR MESSAGES, REVIEWS THE "FAIL" FLAGGED SAMPLES ONLY AND PUSHES THE DATA LOADED TO LIMS. THE BROWSER ONLY SENDS THE DATA THAT IT HAS LOADED, SO THE ELECTRONIC FILE TO LIMS WILL NOT SHOW THE LAST DATA TRANSITIONS

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13655992 ↗

Other Mass Spectrometer, Clinical Use devices

All Mass Spectrometer, Clinical Use devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.