ADVIA Centaur® CEA 10309978Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00630414177311), received between Sep 6, 2018 and Nov 28, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED DISCORDANT (ELEVATED) RESULTS FOR PATIENT SAMPLES WITH ADVIA CENTAUR XP CEA REAGENT LOT 217 ON THE SAME DAY. THE INITIAL RESULTS WERE NOT REPORTED TO PHYSICIAN(S). SAMPLES WERE RETESTED ON THE SAME INSTRUMENT WITH A NEW PACK OF THE SAME LOT. RETEST RESULTS WERE LOWER, CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CEA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18217887 ↗
• MalfunctionMay 18, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY LOW ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED FOR A PATIENT SAMPLE WITH REAGENT LOT 189. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE HIGHER. A SECOND SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP AND THE CEA RESULTS WERE LOW WITH REAGENT LOT 189. THE SECOND SAMPLE WAS ALSO TESTED ON THE TWO ALTERNATE METHODS AND THE RESULTS WERE HIGHER. THE SECOND PATIENT SAMPLE WAS REPEATED ON REAGENT LOT 193 ON THE ADVIA CENTAUR XP. THE RESULT OBTAINED WAS SIMILAR TO THE RESULT FROM LOT 189. THE DISCORDANT RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN. 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 10067922 ↗
• MalfunctionMay 18, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY LOW ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED FOR A PATIENT SAMPLE WITH REAGENT LOT 189. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE HIGHER. A SECOND SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP AND THE CEA RESULTS WERE LOW WITH REAGENT LOT 189. THE SECOND SAMPLE WAS ALSO TESTED ON THE TWO ALTERNATE METHODS AND THE RESULTS WERE HIGHER. THE SECOND PATIENT SAMPLE WAS REPEATED ON REAGENT LOT 193 ON THE ADVIA CENTAUR XP. THE RESULT OBTAINED WAS SIMILAR TO THE RESULT FROM LOT 189. THE DISCORDANT RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN. 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 10067921 ↗
• MalfunctionMay 18, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY LOW ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED FOR A PATIENT SAMPLE WITH REAGENT LOT 189. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE HIGHER. A SECOND SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP AND THE CEA RESULTS WERE LOW WITH REAGENT LOT 189. THE SECOND SAMPLE WAS ALSO TESTED ON THE TWO ALTERNATE METHODS AND THE RESULTS WERE HIGHER. THE SECOND PATIENT SAMPLE WAS REPEATED ON REAGENT LOT 193 ON THE ADVIA CENTAUR XP. THE RESULT OBTAINED WAS SIMILAR TO THE RESULT FROM LOT 189. THE DISCORDANT RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN. 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 10067918 ↗
• MalfunctionMay 18, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY LOW ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED FOR A PATIENT SAMPLE WITH REAGENT LOT 189. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE HIGHER. A SECOND SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP AND THE CEA RESULTS WERE LOW WITH REAGENT LOT 189. THE SECOND SAMPLE WAS ALSO TESTED ON THE TWO ALTERNATE METHODS AND THE RESULTS WERE HIGHER. THE SECOND PATIENT SAMPLE WAS REPEATED ON REAGENT LOT 193 ON THE ADVIA CENTAUR XP. THE RESULT OBTAINED WAS SIMILAR TO THE RESULT FROM LOT 189. THE DISCORDANT RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN. 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 10067916 ↗
• MalfunctionSep 6, 2018No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT NEGATIVE ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED ON A PATIENT SAMPLE DURING PHYSICAL EXAMINATION. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE POSITIVE. THERE IS NO INDICATION OF A CANCER DIAGNOSIS WITH THIS PATIENT AND THE INITIAL NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS TESTED ON THE ALTERNATE METHODS BECAUSE TWO WEEKS AGO THE PATIENT WAS TESTED IN ANOTHER HOSPITAL ON THE TWO ALTERNATE METHODS AND THE RESULTS WERE POSITIVE FOR CEA. BEFORE MEASURING CEA ON THE ADVIA CENTAUR XP, THIS PATIENT TOLD THE PHYSICIAN THE PREVIOUS CEA RESULTS WERE POSITIVE. 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 7852163 ↗
• MalfunctionSep 6, 2018No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT NEGATIVE ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED ON A PATIENT SAMPLE DURING PHYSICAL EXAMINATION. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE POSITIVE. THERE IS NO INDICATION OF A CANCER DIAGNOSIS WITH THIS PATIENT AND THE INITIAL NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS TESTED ON THE ALTERNATE METHODS BECAUSE TWO WEEKS AGO THE PATIENT WAS TESTED IN ANOTHER HOSPITAL ON THE TWO ALTERNATE METHODS AND THE RESULTS WERE POSITIVE FOR CEA. BEFORE MEASURING CEA ON THE ADVIA CENTAUR XP, THIS PATIENT TOLD THE PHYSICIAN THE PREVIOUS CEA RESULTS WERE POSITIVE. 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 7852123 ↗
• MalfunctionSep 6, 2018No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT NEGATIVE ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE POSITIVE. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN. 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 7851417 ↗
• MalfunctionSep 6, 2018No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT NEGATIVE ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE POSITIVE. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN. 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 7851416 ↗
• MalfunctionSep 6, 2018No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT NEGATIVE ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE POSITIVE. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN. 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 7851409 ↗