Atellica CH CO2_c 11097521Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00630414595900), received between Apr 26, 2021 and Sep 28, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “High Test Results” (17 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026High Test Results

  The customer reported that erroneously elevated Carbon Dioxide (CO2, Lot#160071) results were obtained on multiple patient samples on an Atellica CH 930 Analyzer. The initial results were reported to the physician(s) but not questioned. The samples were repeated on the original Atellica CH 930 Analyzer and obtained lower results which were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated CO2 results.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911831 ↗
• MalfunctionMay 5, 2026High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS WERE OBTAINED ON NINE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. FOR SAMPLE IDENTIFIERS (B)(6), THE SAMPLES WERE REPROCESSED TWICE ON THE ORIGINAL ANALYZER. FOR THE OTHER SEVEN SAMPLE IDENTIFIERS, THE SAMPLES WERE REPROCESSED ONCE ON THE ORIGINAL ANALYZER. FOR SAMPLE IDENTIFIER (B)(6), THE FIRST REPROCESSED RESULT WAS THE SAME AS THE INITIAL ERRONEOUS RESULT, AND THE SECOND REPROCESSED WAS LOWER THAN THE PREVIOUS RESULTS. THE SECOND REPROCESSED RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). FOR ALL THE OTHER EIGHT SAMPLE IDENTIFIERS, THE REPROCESSED RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS AND WERE DETERMINED TO BE CORRECT. THE LOWER REPROCESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081660 ↗
• MalfunctionMay 5, 2026High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPROCESSED ON THE ORIGINAL ANALYZER. THE REPROCESSED RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. THE REPROCESSED 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 ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081612 ↗
• MalfunctionMar 9, 2026High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE SAMPLES WERE REPROCESSED ON THE ORIGINAL ANALYZER. THE REPROCESSED RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542916 ↗
• MalfunctionNov 20, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THEY OBTAINED ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C, LOT 150010) RESULTS ON SIXTY-ONE (61) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON ALTERNATE ATELLICA CH 930 ANALYZERS S/N (B)(6) AND S/N (B)(6). LOWER RESULTS WERE 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 CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604315 ↗
• MalfunctionNov 5, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT OUT-OF-RANGE QUALITY CONTROL (QC) RESULTS AND AN ERRONEOUSLY DEPRESSED PATIENT RESULT WERE OBTAINED WITH ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C), LOT# 150174. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAME SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND OBTAINED A HIGHER RESULT WHICH WAS CONSIDERED CORRECT BASED ON THE CLINICAL EXPECTATION OF THE AFFECTED PATIENT. A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476485 ↗
• MalfunctionOct 24, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN, AND IT IS UNKNOWN WHETHER THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ADVIA 1800 INSTRUMENT. 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 CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380607 ↗
• MalfunctionOct 22, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS ON TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). ONE SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER, AND THE OTHER SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. IN BOTH CASES, LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357945 ↗
• MalfunctionJan 3, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON 10 PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULTS AND MATCHED THE PATIENT'S HISTORY. 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 FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065469 ↗
• MalfunctionNov 22, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CI 1900 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CI 1900 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 CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756043 ↗
• MalfunctionNov 22, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CI 1900 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CI 1900 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 CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756029 ↗
• MalfunctionNov 21, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FOURTEEN (14) ERRONEOUSLY DEPRESSED CARBON DIOXIDE, CONCENTRATED (CO2_C) PATIENT SAMPLE RESULTS ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746961 ↗
• MalfunctionNov 7, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRONEOUS DEPRESSED CARBON DIOXIDE, CONCENTRATED (CO2_C) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. IT IS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE HIGHER 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 ERRONEOUS DEPRESSED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631048 ↗
• MalfunctionOct 1, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN ERRONEOUS DEPRESSED CARBON DIOXIDE, CONCENTRATED (CO2_C) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. 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 IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS DEPRESSED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344036 ↗
• MalfunctionJul 2, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS ON FOUR (4) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. LOWER REPROCESSED RESULTS WERE OBTAINED AND CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19654454 ↗
• MalfunctionMay 8, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CH (B)(6) 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 (B)(6) ANALYZER AND ON THE ORIGINAL ATELLICA CH (B)(6) ANALYZER. LOWER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267112 ↗
• MalfunctionApr 26, 2024High Test Results; High Test Results

  A FALSELY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ATELLICA ® CI 1900 ANALYZER. THE FALSELY ELEVATED PATIENT SAMPLE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA ® CI 1900 ANALYZER AND A LOWER RESULT WAS OBTAINED. THE LOWER RESULT WAS CONSIDERED CORRECT. THE ANION GAP WAS ACCEPTABLE, AND THE LOWER RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195886 ↗
• MalfunctionFeb 1, 2024High Test Results; High Test Results

  EIGHT (8) DISCORDANT FALSELY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS ON SEVEN (7) PATIENT SAMPLES WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE FALSELY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. LOWER RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION AND ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622266 ↗
• MalfunctionDec 28, 2022High Test Results; High Test Results

  A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT PRODUCED A NEGATIVE ANION GAP, FAILED DELTA CHECK, AND THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE ORIGINAL INSTRUMENT. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT AND GAVE A POSITIVE ANION GAP. 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 ELEVATED CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060613 ↗
• MalfunctionNov 22, 2022High Test Results; High Test Results

  MULTIPLE DISCORDANT CONCENTRATED CARBON DIOXIDE (CO2_C) PATIENT TEST RESULTS WERE OBTAINED FROM AN ATELLICA CH 930 ANALYZER. THE CUSTOMER PROVIDED ONLY ONE EXAMPLE OF A FALSELY ELEVATED CARBON DIOXIDE (CO2_C) TEST RESULT FOR ONE PATIENT SAMPLE. THE INITIAL TEST RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME ANALYZER. THE REPEAT TEST 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15843404 ↗
• MalfunctionApr 26, 2021High Test Results; High Test Results

  FIVE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER USING ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C) REAGENT (LOT NUMBER: 100274). THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED FOR CO2_C, RECOVERING LOWER. 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, FALSELY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724832 ↗