ADVIA Centaur® CEA 10309977Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00630414177304), received between Aug 3, 2017 and Dec 30, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “High 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Low Readings; Low Readings

  THE CUSTOMER REPORTS REPRODUCIBLE LOW ADVIA CENTAUR XP CEA RESULTS ON DIFFERENT SAMPLES FROM A MALE PATIENT UNDER TREATMENT FOR COLON CANCER THAT WERE DISCORDANT RELATIVE TO HIGHER ALTERNATE METHOD TESTING RESULTS. AN INITIAL LOW ADVIA CENTAUR XP CEA RESULT ((B)(6) 2025) WAS REPORTED AND QUESTIONED, AND THE PATIENT WAS REDRAWN AT ANOTHER LOCATION FOR TESTING WITH ALTERNATE METHOD. THE RESULT WAS HIGHER AND CONSIDERED CORRECT. THE PATIENT RETURNED TO THE CUSTOMER SITE AND WAS REDRAWN AND TESTED WITH ADVIA CENTAUR XP CEA, WHICH AGAIN RESULTED LOW ((B)(6) 2025). THE CUSTOMER SENT THIS SAMPLE TO OTHER LABS FOR RETESTING WITH ALTERNATE METHODS AND A DIFFERENT ADVIA CENTAUR XP. THE ALTERNATE METHOD RESULTS WERE AGAIN HIGHER AND AN ADVIA CENTAUR RESULT WAS LOW, CONFIRMING A DISCORDANCE BETWEEN METHODS. THERE HAVE BEEN NO ALLEGATIONS OF ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931617 ↗
• MalfunctionDec 30, 2025Low Readings; Low Readings

  THE CUSTOMER REPORTS REPRODUCIBLE LOW ADVIA CENTAUR XP CEA RESULTS ON DIFFERENT SAMPLES FROM A MALE PATIENT UNDER TREATMENT FOR COLON CANCER THAT WERE DISCORDANT RELATIVE TO HIGHER ALTERNATE METHOD TESTING RESULTS. AN INITIAL LOW ADVIA CENTAUR XP CEA RESULT (ON (B)(6) 2025) WAS REPORTED AND QUESTIONED, AND THE PATIENT WAS REDRAWN AT ANOTHER LOCATION FOR TESTING WITH ALTERNATE METHOD. THE RESULT WAS HIGHER AND CONSIDERED CORRECT. THE PATIENT RETURNED TO THE CUSTOMER SITE AND WAS REDRAWN AND TESTED WITH ADVIA CENTAUR XP CEA, WHICH AGAIN RESULTED LOW (ON (B)(6) 2025). THE CUSTOMER SENT THIS SAMPLE TO OTHER LABS FOR RETESTING WITH ALTERNATE METHODS AND A DIFFERENT ADVIA CENTAUR XP. THE ALTERNATE METHOD RESULTS WERE AGAIN HIGHER AND AN ADVIA CENTAUR RESULT WAS LOW, CONFIRMING A DISCORDANCE BETWEEN METHODS. THERE HAVE BEEN NO ALLEGATIONS OF ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931615 ↗
• MalfunctionMay 1, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR CARCINOEMBRYONIC ANTIGEN (CEA) RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER AND PRODUCED A LOWER RESULT. THIS LOWER REPEAT RESULT MATCHED THE PATIENT'S LAB HISTORY FOR CEA, AND WAS REPORTED AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221923 ↗
• MalfunctionJul 22, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A DEPRESSED ADVIA CENTAUR XPT CEA RESULT FOR A PATIENT SAMPLE. THE SAMPLE WAS RETESTED USING AN ALTERNATE TEST METHOD AND THE RESULT WAS HIGHER. THE CUSTOMER CONTACTED SIEMENS BECAUSE OF THE DIFFERENCE IN RESULTS. IT HAS NOT BEEN CONFIRMED WHICH RESULT IS TRUE. HOWEVER; COMPLAINT INFORMATION INDICATES THAT THE PHYSICIAN BELIEVED THAT THE DEPRESSED ADVIA CENTAUR XPT CEA RESULT WAS DISCORDANT COMPARED THE CLINICAL PICTURE OF THE PATIENT. ADDITIONALLY, THE CUSTOMER CONTACTED THE PATIENT DIRECTLY FOR ANOTHER SAMPLE TO PERFORM FURTHER TESTING. THE SAMPLE WAS OBTAINED APPROXIMATELY A MONTH LATER AND WAS TESTED ON THE SAME ADVIA CENTAUR XPT INSTRUMENT AS THE INITIAL RESULT AND THE RESULT WAS ALSO DEPRESSED. THE SAMPLE WAS TESTED ON ALTERNATE METHODS AT NON-CUSTOMER SITES AND 1 RESULT WAS HIGH AND ONE RESULT WAS DEPRESSED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089671 ↗
• MalfunctionMay 21, 2022Low Test Results; Low Test Results

  A FALSELY DEPRESSED CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR CP INSTRUMENT. THE FALSELY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). ON THE FOLLOWING DAY, (B)(6) 2022, THE SAMPLE WAS REPEATED AT AN ALTERNATE LAB ON AN ADVIA CENTAUR XPT INSTRUMENT. THE SAMPLE WAS THEN DILUTED 1:10 AND REPEATED ON THE INITIAL INSTRUMENT. THE RESULT WAS HIGHER THAN THE INITIAL DISCORDANT RESULT. ON (B)(6) 2022, THE SAMPLE WAS REPEATED ON THE INITIAL INSTRUMENT AND THE RESULT RECOVERED AT >100 NG/ML. THE REPEAT RESULT FROM THE ALTERNATE INSTRUMENT WAS REPORTED AS THE CORRECT RESULT, TO THE PHYSICIAN. THE HIGHER RESULTS WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466094 ↗
• MalfunctionAug 7, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED AN ADVIA CENTAUR XP CARCINOEMBRYONIC ANTIGEN (CEA) RESULT THAT WAS ELEVATED COMPARED TO REPEAT TESTING. THE ELEVATED RESULT WAS NOT REPORTED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP CEA RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10382140 ↗
• MalfunctionDec 23, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSELY ELEVATED ADVIA CENTAUR XP CEA RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE ELEVATED RESULT WAS REPORTED TO THE CLINICIAN AND WAS QUESTIONED. THE LABORATORY QUERIED THE PAST RESULTS AND WERE ALL NEGATIVE. THE PATIENT SAMPLE WAS REPEATED ON ANOTHER ADVIA CENTAUR XP AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS REPEATED ON THE INITIAL ADVIA CENTAUR XP AND THE RESULT WAS NEGATIVE. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9511030 ↗
• MalfunctionJun 28, 2019No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY ELEVATED ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED FOR FOUR SAMPLES FROM DIFFERENT PATIENTS WHEN COMPARING REAGENT LOT 178 AND REAGENT LOT 185. THE RESULTS FROM LOT 185 WERE ELEVATED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8743719 ↗
• MalfunctionMay 30, 2019No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT ADVIA CENTAUR XPT CEA RESULTS WERE OBTAINED ON SAMPLES FROM FOUR PATIENTS DURING A COMPARISON STUDY. THE COMPARISON STUDY WAS COMPARING THE PREVIOUS LOT WITH THE NEW LOT THAT CONTAINED A NEW ANTIBODY POOL. THE RESULTS WITH THE NEW LOT WERE HIGHER. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT CEA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654231 ↗
• MalfunctionMar 14, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE HIGH ADVIA CENTAUR XP CEA RESULT WAS OBTAINED ON A PATIENT SAMPLE (B)(6). THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PHYSICIAN THOUGHT THE RESULT SHOULD BE LOWER. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS LOWER. THE LOWER RESULT WAS REPORTED. THE CUSTOMER DECIDED TO REPEAT APPROXIMATELY NINE OTHER SAMPLES THAT WERE RUN AROUND THE SAME TIME THAT PATIENT WAS ON (B)(6) 2019 ON THE SAME ADVIA CENTAUR XP. THE REPEAT RESULTS FOR (4) SAMPLES WERE LOWER. CORRECTED REPORTS WERE ISSUED. THE CUSTOMER DECIDED TO FURTHER REVIEW ALL CEA RESULTS FROM (B)(6) 2019 AND IDENTIFIED 179 TESTS FOR CEA WERE PROCESSED THAT DAY. APPROXIMATELY 50 RESULTS WERE FROM AROUND THE TIME FRAME OF (B)(6). THE CUSTOMER PERFORMED REPEAT TESTING WITH AVAILABLE SAMPLES ON ANOTHER ADVIA CENTAUR XP IN THE LABORATORY. FOURTEEN CORRECTED REPORTS WERE SENT TO THE PHYSICIAN. THE CUSTOMER WAS NOT ABLE TO REPEAT ALL QUESTIONABLE RESULTS BECAUSE SAMPLES WERE NO LONGER AVAILABLE. THEY CONTACTED THE PHYSICIANS AND INFORMED THEM OF THE DISCORDANT RESULTS AND RECOMMENDED PATIENTS BE REDRAWN FOR REPEAT TESTING. ADDITIONAL SAMPLE DATA FOR THESE RESULTS WAS NOT PROVIDED. IT IS UNKNOWN IF PATIENT TREAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8421208 ↗
• MalfunctionNov 16, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE LOW (NORMAL) ADVIA CENTAUR XPT CEA RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. A NEW SAMPLE (SECOND SAMPLE) WAS OBTAINED BY THE LABORATORY. THE PATIENT SAMPLE WAS TESTED AND THE RESULT WAS NORMAL. THE LABORATORY PERFORMED MANUAL AND AUTOMATIC DILUTIONS AND THE RESULTS WERE NORMAL. THE SECOND SAMPLE WAS SENT TO (2) SUPPORT LABORATORIES USING THE SAME ALTERNATE METHOD FOR TESTING AND THE RESULTS WERE HIGH. A CORRECTED REPORT WAS ISSUED. PATIENT UNDERGOING CANCER TREATMENT. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8081205 ↗
• MalfunctionNov 16, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE LOW (NORMAL) ADVIA CENTAUR XPT CEA RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. A NEW SAMPLE (SECOND SAMPLE) WAS OBTAINED BY THE LABORATORY. THE PATIENT SAMPLE WAS TESTED AND THE RESULT WAS NORMAL. THE LABORATORY PERFORMED MANUAL AND AUTOMATIC DILUTIONS AND THE RESULTS WERE NORMAL. THE SECOND SAMPLE WAS SENT TO (2) SUPPORT LABORATORIES USING THE SAME ALTERNATE METHOD FOR TESTING AND THE RESULTS WERE HIGH. A CORRECTED "REPROT" WAS ISSUED. PATIENT UNDERGOING CANCER TREATMENT. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8081197 ↗
• MalfunctionNov 16, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE LOW (NORMAL) ADVIA CENTAUR XPT CEA RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. A NEW SAMPLE (SECOND SAMPLE) WAS OBTAINED BY THE LABORATORY. THE PATIENT SAMPLE WAS TESTED AND THE RESULT WAS NORMAL. THE LABORATORY PERFORMED MANUAL AND AUTOMATIC DILUTIONS AND THE RESULTS WERE NORMAL. THE SECOND SAMPLE WAS SENT TO (2) SUPPORT LABORATORIES USING THE SAME ALTERNATE METHOD FOR TESTING AND THE RESULTS WERE HIGH. A CORRECTED REPORT WAS ISSUED. PATIENT UNDERGOING CANCER TREATMENT. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8081193 ↗
• MalfunctionAug 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FALSE LOW ADVIA CENTAUR XPT CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WERE OBTAINED ON A PATIENT AND CONSIDERED DISCORDANT COMPARED TO HIGHER CEA RESULTS WHEN TESTED ON AN ALTERNATE TEST METHOD AT ANOTHER HOSPITAL. THE PHYSICIAN QUESTIONED THE LOWER ADVIA CENTAUR XPT CEA RESULTS AS THEY DO NOT REFLECT THE PATIENT'S CLINICAL HISTORY. THE LABORATORY REPORTED BOTH THE ADVIA CENTAUR XPT CEA RESULT, AND THE ALTERNATE CEA TEST METHOD RESULT TO THE PHYSICIAN. THERE IS NO KNOWN REPORT THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT CEA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6765408 ↗