Atellica CH GluH_3 11097592Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414596488), received between Nov 1, 2018 and Jul 8, 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.

• MalfunctionJul 8, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED ERRONEOUSLY ELEVATED GLUCOSE HEXOKINASE_3 (GLUH_3) RESULTS ON PATIENT SAMPLES THAT WERE OBTAINED ON THE ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN. THE SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. DATA IS UNAVAILABLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED GLUCOSE HEXOKINASE_3 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696517 ↗
• MalfunctionNov 1, 2018Mechanical Problem; Mechanical Problem

  A DISCORDANT, FALSELY HIGH GLUCOSE (GLUH_3) TEST RESULT WAS OBTAINED FROM AN ATELLICA CH 930 CHEMISTRY INSTRUMENT. THE SAME SAMPLE WAS REPEATED AUTOMATICALLY ON THE SAME INSTRUMENT GIVING A LOWER TEST RESULT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND IS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY HIGH GLUCOSE (GLUH_3) TEST RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8028667 ↗