Atellica CH Ca 11097595Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00630414595672), received between Mar 28, 2023 and Aug 26, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 reports).

3 other recalls cover devices cleared under the same FDA submission (K991576); they may or may not involve this specific model.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS ONE (1) CALCIUM (CA) DISCORDANT PATIENT SAMPLE RESULT WAS OBTAINED WHEN PROCESSED TWICE ON AN ATELLICA CH 930 ANALYZER. IT IS UNKNOWN WHICH OF THE RESULTS 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 CALCIUM (CA) PATIENT SAMPLE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897839 ↗
• MalfunctionAug 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS ONE (1) CALCIUM (CA) DISCORDANT PATIENT SAMPLE RESULT WAS OBTAINED WHEN PROCESSED ON MULTIPLE ATELLICA CH 930 ANALYZERS. IT IS UNKNOWN WHICH OF THE RESULTS IS CORRECT OR IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCIUM (CA) PATIENT SAMPLE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851087 ↗
• MalfunctionAug 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THREE (3) CALCIUM (CA) DISCORDANT PATIENT SAMPLE RESULTS WERE OBTAINED WHEN PROCESSED ON MULTIPLE ATELLICA CH 930 ANALYZERS. IT IS UNKNOWN WHICH OF THE RESULTS 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 CALCIUM (CA) PATIENT SAMPLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850375 ↗
• MalfunctionJul 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED CALCIUM (CA) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CALCIUM (CA) PATIENT SAMPLE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578296 ↗
• MalfunctionJun 25, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS ONE (1) ERRONEOUSLY DEPRESSED CALCIUM (CA) PATIENT SAMPLE RESULT OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED RESULT WITH CALCIUM (CA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326815 ↗
• MalfunctionMay 30, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT AN ERRONEOUSLY ELEVATED CALCIUM (CA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULT RECOVERED LOWER THAN THE ERRONEOUS RESULT AND WAS CONSIDERED CORRECT. HOWEVER, A CORRECTED REPORT WAS NOT ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CALCIUM (CA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112704 ↗
• MalfunctionDec 5, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY ELEVATED CALCIUM (CA) RESULTS ON TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. THE LOWER REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CALCIUM (CA) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20851503 ↗
• MalfunctionOct 9, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED A DISCORDANT ELEVATED CALCIUM (CA) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE CUSTOMER STATED THAT THE SAMPLE WAS UNAVAILABLE FOR REPEAT TESTING, AND IT IS UNKNOWN WHETHER ANY REPEAT OR REDRAW TESTING WAS PERFORMED LATER. THE CORRECT RESULT FOR THIS PATIENT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CALCIUM (CA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20405877 ↗
• MalfunctionOct 9, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED A DISCORDANT ELEVATED CALCIUM (CA) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE CUSTOMER STATED THAT THE SAMPLE WAS UNAVAILABLE FOR REPEAT TESTING, AND IT IS UNKNOWN WHETHER ANY REPEAT OR REDRAW TESTING WAS PERFORMED LATER. THE CORRECT RESULT FOR THIS PATIENT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CALCIUM (CA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20405862 ↗
• MalfunctionJun 6, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED CALCIUM (CA) PATIENT SAMPLE RESULT ON AN ATELLICA CH (B)(4) ANALYZER. THE ERRONEOUS PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH (B)(4) ANALYZER. THE LOWER REPROCESSED RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CALCIUM (CA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475982 ↗
• MalfunctionJan 5, 2024Low Test Results; Low Test Results

  A DISCORDANT FALSELY DEPRESSED CALCIUM (CA) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE FALSELY DEPRESSED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA ® CH 930 ANALYZER. THE HIGHER REPROCESSED RESULT OBTAINED WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CALCIUM (CA) PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18453604 ↗
• MalfunctionMar 28, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A DEPRESSED ERRONEOUS CALCIUM (CA) RESULT ON A PATIENT SAMPLE ON ATELLICA CH 930 ANALYZER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULT WAS HIGHER THAN THE DISCORDANT 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 DISCORDANT CA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629268 ↗
• MalfunctionMar 28, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ERRONEOUS CALCIUM (CA) RESULTS ON MULTIPLE PATIENT SAMPLES ON ATELLICA CH 930 ANALYZER. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME ATELLICA CH 930 ANALYZER. THE REPEAT RESULTS WERE LOWER THAN THE DISCORDANT RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629267 ↗
• MalfunctionMar 28, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ERRONEOUS CALCIUM (CA) RESULTS ON MULTIPLE PATIENT SAMPLES ON ATELLICA CH 930 ANALYZER. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON A ATELLICA CH 930 ANALYZER. THE REPEAT RESULTS WERE LOWER THAN THE DISCORDANT RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629266 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991576. One submission often covers many models, so check the product and lot details in each record.

• Z-1498-2022 · Jun 28, 2022 · Open, Classified
  Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
• Z-2062-2018 · Mar 27, 2018 · Terminated
  ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
• Z-1658-2016 · Mar 17, 2016 · Terminated
  Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated