Atellica CH CYSC_2 11097647Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414236919), received between Sep 18, 2025 and Sep 18, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED DISCORDANT CYSTATIN C_2 (CYSC_2) RESULTS ON TWO (2) PATIENT SAMPLES WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. IT IS UNKNOWN WHICH RESULTS ARE CORRECT OR IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088239 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED A DISCORDANT CYSTATIN C_2 (CYSC_2) RESULT ON ONE (1) PATIENT SAMPLE WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. IT IS UNKNOWN WHICH RESULT IS CORRECT OR IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088100 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED A DISCORDANT CYSTATIN C_2 (CYSC_2) RESULT ON ONE (1) PATIENT SAMPLE WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. IT IS UNKNOWN WHICH RESULT IS CORRECT OR IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088070 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ONE (1) DISCORDANT DEPRESSED CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULT WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. THE PATIENT SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CH ANALYZER TWICE AND THE RESULTS WERE HIGHER. IT IS UNKNOWN WHICH RESULT IS CORRECT OR IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085901 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ONE (1) DISCORDANT DEPRESSED CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULT WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. THE PATIENT SAMPLE WAS PROCESSED ON AN ALTERNATE ATELLICA CH ANALYZER AND THE RESULT WAS HIGHER. IT IS UNKNOWN WHICH RESULT IS CORRECT OR IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085739 ↗
• MalfunctionSep 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ONE (1) DISCORDANT DEPRESSED CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULT WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. THE PATIENT SAMPLE WAS PROCESSED ON AN ALTERNATE ATELLICA CH ANALYZER AND THE RESULT WAS HIGHER. IT IS UNKNOWN WHICH RESULT IS CORRECT OR IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S).THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085697 ↗