ADVIA® Chemistry CO2_c Reagents Concentrated 10283345Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00630414553177), received between Feb 23, 2018 and Aug 26, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULTS ON THREE (3) PATIENT SAMPLES ON AN ADVIA CHEMISTRY XPT SYSTEM. THE ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ADVIA CHEMISTRY XPT SYSTEM. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND NOT 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 22893297 ↗
• MalfunctionApr 28, 2023Low Test Results; Low Test Results

  A FALSELY DEPRESSED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT, S/N: (B)(6). THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CHEMISTRY XPT INSTRUMENT, S/N: (B)(6). THE REPEAT RESULT WAS HIGHER THAN THE INITIAL 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 DISCORDANT CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16834837 ↗
• MalfunctionDec 21, 2021High Test Results; High Test Results

  A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2 C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AT AN ALTERNATE FACILITY. THE CUSTOMER DID NOT PROVIDE THE REPEAT RESULT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CO2 C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056229 ↗
• MalfunctionDec 21, 2021High Test Results; High Test Results

  A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2 C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT USING LOT 100. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS SENT TO AN ALTERNATE FACILITY FOR TESTING. THE CUSTOMER DID NOT PROVIDE THE REPEAT RESULT. ON (B)(6) 2021, THE PATIENT RETESTED FOR CO2 C, USING A DIFFERENT SAMPLE AND THE RESULT ALSO RECOVERED HIGH. THIS ELEVATED RESULT, SAMPLE ID (B)(4), IS ADDRESSED IN MDR 2432235-2021-00297. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CO2 C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056225 ↗
• MalfunctionDec 21, 2021High Test Results; High Test Results

  A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT USING LOT 100. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED AT AN ALTERNATE FACILITY. THE CUSTOMER DID NOT PROVIDE THE REPEAT RESULT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056205 ↗
• MalfunctionDec 21, 2021High Test Results; High Test Results

  A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AT AN ALTERNATE FACILITY. THE CUSTOMER DID NOT PROVIDE THE REPEAT RESULT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CO2_C RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056164 ↗
• MalfunctionDec 21, 2021High Test Results; High Test Results

  A FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON AN ADVIA CHEMISTRY XPT INSTRUMENT, USING LOT 100. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS SENT TO AN ALTERNATE LABORATORY FOR TESTING. THE CUSTOMER DID NOT PROVIDE THE REPEAT RESULT. ON (B)(6) 2021, THE PATIENT WAS REDRAWN AND THE NEW SAMPLE, IDENTIFIED AS (B)(6) , WAS PROCESSED AND THE RESULT RECOVERED HIGHER. THE RESULT OBTAINED ON THE NEW SAMPLE WAS ALSO CONSIDERED DISCORDANT AND WAS REPORTED TO THE PHYSICIAN(S). THE RESULT OBTAINED ON (B)(6) 2021 WAS ADDRESSED IN MDR 2432235-2021-00306. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056156 ↗
• MalfunctionDec 21, 2021High Test Results; High Test Results

  TWO FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) PATIENT RESULTS WERE OBTAINED ON AN ADVIA CHEMISTRY XPT INSTRUMENT USING LOT 100. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND A PHYSICIAN QUESTIONED THE RESULT FOR SAMPLE ID (B)(6). THE SAMPLES WERE SENT TO AN ALTERNATE LABORATORY FOR TESTING AND THE RESULT FOR SAMPLE ID (B)(6) RECOVERED LOWER. THE CUSTOMER DID NOT PROVIDE THE REPEAT RESULT FOR SAMPLE ID (B)(6). THE PATIENT OF SAMPLE ID (B)(6) WAS ALSO TESTED FOR CO2_C, USING A DIFFERENT SAMPLE, ON (B)(6) 2021 AND THE RESULT ALSO RECOVERED HIGH. THIS ELEVATED RESULT IS ADDRESSED IN MDR 2432235-2021-00299. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056151 ↗
• MalfunctionDec 21, 2021High Test Results; High Test Results

  TWO FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON AN ADVIA CHEMISTRY XPT INSTRUMENT, USING LOT 100. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE SENT TO AN ALTERNATE LABORATORY FOR TESTING. THE CUSTOMER DID NOT PROVIDE THE REPEAT RESULTS. THE PATIENT OF THE SAMPLE IDENTIFIED WITH (B)(6) WAS INITIALLY PROCESSED ON (B)(6) 2021 AND AN ELEVATED CO2_C RESULT WAS ALSO OBTAINED ON THE SAMPLE. THE RESULT OBTAINED ON (B)(6) 2021 WAS ADDRESSED IN MDR 2432235-2021-00298. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CO2_C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056128 ↗
• MalfunctionJul 20, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT BEGINNING IN (B)(6) 2020, DISCORDANT, FALSELY DEPRESSED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON SAMPLES FROM THE SAME PATIENT ON AN ADVIA CHEMISTRY XPT INSTRUMENT USING REAGENT LOT 070. SAMPLES ARE BEING DRAWN FROM THIS IN-PATIENT EVERY DAY AND THE SAMPLES RECOVERED AT 10-12 MMOL/L FOR CO2_C DAILY. ON (B)(6) 2020, A PHYSICIAN QUESTIONED THE RESULTS AND A SAMPLE FROM THE PATIENT WAS REPEATED ON AN ALTERNATE NON-SIEMENS INSTRUMENT AND AN ALTERNATE BLOOD GAS ANALYZER. THE RESULTS OBTAINED ON THE ALTERNATE INSTRUMENTS RECOVERED HIGHER AND THE PATIENT'S CLINICAL PICTURE GAVE THE CUSTOMER CONFIDENCE THAT THE RESULT FROM THE BLOOD GAS ANALYZER WAS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CO2_C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10299473 ↗
• MalfunctionJul 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA 1800 INSTRUMENT, WHILE USING REAGENT LOT 010. THE INITIAL RESULTS FOR TEN PATIENT SAMPLES WERE REPORTED TO THE PHYSICIAN(S). THE DISCORDANT RESULTS FOR THE REST OF THE PATIENT SAMPLES WERE NOT REPORTED TO THE PHYSICIAN(S). AFTER REPLACING THE REAGENT WEDGE, THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER. THE CORRECTED RESULTS FOR FIVE OF TEN PATIENT SAMPLES WERE REPORTED TO THE PHYSICIAN(S), AS THE DISCORDANT RESULTS FOR THOSE SAMPLES WERE INITIALLY REPORTED. IT IS UNKNOWN IF THE OTHER FIVE SAMPLES REPEATED SAME. THE REPEAT RESULTS WERE REPORTED FOR THE REST OF THE SAMPLES. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7705894 ↗
• MalfunctionFeb 23, 2018Mechanical Problem; Mechanical Problem

  DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULTS WERE OBTAINED ON 2 SAMPLES ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND THEY RESULTED LOWER. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7293808 ↗