Syva® Emit® 2000 Gentamicin Plus Assay 10445333Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842768001086), received between Feb 23, 2024 and Mar 5, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2024High Test Results; High Test Results

  A FALSELY ELEVATED SYVA® EMIT® 2000 GENTAMICIN PLUS ASSAY RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A VIVA-PROE SYSTEM (SN: (B)(6)). THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE PATIENT WAS TAKING GENTAMICIN, BUT THE RESULT WAS FLAGGED BY THE CLINICAL TEAM AND BELIEVED TO BE PHARMACOKINETICALLY IMPLAUSIBLE IN THE LIGHT OF TREATMENT GIVEN AND SUBSEQUENT RESULT. THE SAMPLE WAS INSUFFICIENT IN VOLUME TO PERFORM REPEAT TESTING. TRUE VALUE WAS NOT PROVIDED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SYVA® EMIT® 2000 GENTAMICIN PLUS ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835823 ↗
• MalfunctionFeb 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT SYVA® EMIT® 2000 GENTAMICIN PLUS ASSAY RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON A VIVA-PROE SYSTEM (SN: (B)(6)). FOR ONE OF THE SAMPLES, SID (B)(6), THE ERRONEOUS RESULT WAS REPORTED, AND THE RESULT WAS QUESTIONED. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND AN ALTERNATE VIVA-PROE SYSTEM (SN: (B)(6)). THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT FROM THE ALTERNATE INSTRUMENT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). FOR THE OTHER TWO SAMPLES, SID (B)(6) AND SID (B)(6), THE INITIAL RESULTS WERE REPORTED AND WERE NOT QUESTIONED. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE LOWER THAN THE INITIAL RESULTS. THE REPEAT RESULTS WERE NOT REPORTED. THE CUSTOMER HAS SINCE COMMUNICATED THAT THESE TWO SAMPLES ARE NOT CONSIDERED TO BE A PART OF THE ISSUE BECAUSE NO ISSUES WERE FLAGGED OR DETECTED IN RELATION TO THE ANALYSIS OF THE SPECIMENS. IT IS UNCLEAR WHICH RESULT WAS CONSIDERED CORRECT (INITIAL OR REPEAT). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SYVA® EMIT® 2000 GENTAMICIN PLUS ASSAY RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769318 ↗