Syva® Emit® Amikacin Assay 10445383Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842768001543), received between Dec 8, 2021 and Jul 14, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Low Test Results; Low Test Results

  A FALSELY LOW AMIKACIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 SYSTEM USING SYVA EMIT AMIKACIN REAGENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). AFTER QUALITY CONTROLS (QC) RECOVERED OUT OF RANGE THE FOLLOWING DAY, THE INITIAL AMIKACIN RESULT WAS QUESTIONED, AND THE SAMPLE WAS REPEATED FOR AMIKACIN AND RECOVERED HIGHER. THE HIGHER RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496845 ↗
• MalfunctionSep 22, 2023High Test Results; High Test Results

  CUSTOMER OBTAINED A FALSELY ELEVATED SYVA EMIT AMIKACIN (AMIK), LOT R2, PATIENT RESULT ON AN ATELLICA CH 930 ANALYZER. THE INITIAL UNDILUTED SERUM SAMPLE RESULT WAS GREATER THAN THE ANALYTICAL MEASURING RANGE WHEN IT WAS TESTED NEAT AND DILUTED. THE INITIAL DILUTED RESULT WAS DISCORDANT COMPARED TO THE REPEAT DILUTED RESULTS TESTED ON THE SAME ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. IT IS UNKNOWN WHAT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798263 ↗
• MalfunctionDec 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A PATIENT SAMPLE WAS INITIALLY PROCESSED FOR AMIKACIN ON AN ATELLICA CH 930 ANALYZER USING THE EMIT AMIKACIN ASSAY, AND THE SAMPLE RECOVERED 50 UG/ML. THE INITIAL RESULT WAS CONSIDERED DISCORDANT AND WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS MANUALLY DILUTED USING THE LEVEL 0 CALIBRATOR AND REPEATED TWICE ON THE SAME INSTRUMENT AND THE SAMPLE RECOVERED LOWER. THE REPEAT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER INDICATED THAT THEY SENT A RECOMMENDATION TO RECOLLECT THE SAMPLE AS THE AFFECTED SAMPLE WAS NOT SUFFICIENT FOR RETESTING. THE CORRECT RESULT FOR THIS PATIENT IS UNKNOWN AND THE CUSTOMER DOES NOT RECALL WHETHER THE PATIENT WAS REDRAWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AMIKACIN RESULT(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961443 ↗