Atellica CH Dgn 11097526Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414595863), received between Jul 30, 2021 and Nov 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low 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 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.

• MalfunctionNov 6, 2023Low Test Results; Low Test Results

  A FALSELY DEPRESSED DIGOXIN (DGN) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE INITIAL ATELLICA CH 930 ANALYZER. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT 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 FALSELY DEPRESSED DIGOXIN (DGN) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072875 ↗
• MalfunctionJul 30, 2021Low Test Results; Low Test Results

  SIX FALSELY DEPRESSED DIGOXIN (DGN) PATIENT SAMPLE TEST RESULTS WERE OBTAINED FROM AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME PATIENT SAMPLES WERE REPEATED ON AN ALTERNATE ANALYZER. THE REPEAT RESULTS WERE HIGHER AND WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED DGN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256349 ↗