Emit® 2000 Vancomycin Assay 10445338Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768023323), received between Jun 25, 2020 and Jun 25, 2020 — 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 16, 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.

• MalfunctionJun 25, 2020High Test Results; High Test Results

  AN ELEVATED EMIT 200 VANCOMYCIN RESULT, CONSIDERED BY THE PHYSICIAN TO BE DISCORDANT, WAS OBTAINED ON A PATIENT SAMPLE ON A BECKMAN AU5800 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON THE SAME SYSTEM AND ELEVATED RESULTS WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE VANCOMYCIN RESULTS WHICH WERE REGARDED AS DISCORDANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194316 ↗
• MalfunctionJun 25, 2020High Test Results; High Test Results

  AN ELEVATED EMIT 200 VANCOMYCIN RESULT, CONSIDERED BY THE PHYSICIAN TO BE DISCORDANT, WAS OBTAINED ON A PATIENT SAMPLE ON A BECKMAN AU5800 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPROCESSED ON THE SAME SYSTEM AND ELEVATED RESULTS WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE VANCOMYCIN RESULTS WHICH WERE REGARDED AS DISCORDANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194313 ↗