ADVIA Centaur® CA 15-3® 10327620Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00630414461311), received between Sep 30, 2019 and Oct 15, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Low 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.

• MalfunctionOct 15, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBSERVATION OF A DEPRESSED ADVIA CENTAUR CANCER ANTIGEN 15-3 (CA 15-3) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT# 221. AN INITIAL DEPRESSED RESULT WAS OBTAINED FOR THE PATIENT SAMPLE IN QUESTION. THE DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAME SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER WHICH OBTAINED A HIGHER RESULT. THEN, THE SAMPLE WAS REPEATED ON AN ALTERNATE ANALYZER WHICH PRODUCED A SIMILAR HIGHER RESULT. THE HIGHER RESULTS WERE CONSIDERED CORRECT, AND THE RESULT OBTAINED ON THE ORIGINAL ANALYZER WAS REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THERE WAS AN EXISTING CANCER DIAGNOSIS WITH THE AFFECTED PATIENT, BUT THE CUSTOMER CONFIRMED THAT THE PATIENT WAS TESTED FOR ONCOLOGY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299315 ↗
• MalfunctionNov 12, 2024Low Test Results; Low Test Results

  THE CUSTOMER NOTIFIED SIEMENS OF DISCORDANT LOW PATIENT RESULTS WITH ADVIA CENTAUR XP CA 15-3, LOT 217 CALIBRATED WITH C4376. THE ISSUE WAS IDENTIFIED DURING ROUTINE TROUBLESHOOTING WITH THE CUSTOMER FOR OUT-OF-RANGE QUALITY CONTROL (QC), WHEN THE PATIENT SAMPLES TESTED BEFORE THE QC ISSUE WERE RETESTED WHEN QC WAS BACK IN RANGE. THE PATIENT RETEST RESULTS WERE HIGHER THAN THE INITIAL RESULTS AND WERE CONSIDERED CORRECT. THE INITIAL DEPRESSED PATIENT RESULTS WERE REPORTED TO THE PHYSICIANS, BUT NOT QUESTIONED. CORRECTED REPORTS WERE ISSUED TO THE PHYSICIANS USING THE HIGHER RETEST RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662206 ↗
• MalfunctionMay 17, 2022Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER OBSERVED A DISCORDANT CA 15-3 RESULT ON THE ADVIA CENTAUR CP FOR ONE PATIENT COMPARED TO A RESULT ON ANOTHER ADVIA CENTAUR CP AT ANOTHER SITE. IT IS UNKNOWN WHICH RESULT IS CORRECT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED DUE TO THE DISCORDANT ADVIA CENTAUR CP CA 15-3 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14417903 ↗
• MalfunctionApr 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER IS QUESTIONING ADVIA CENTAUR XPT CA15-3 RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH ONE REAGENT LOT. THIS CUSTOMER TRANSITIONED FROM IMMULITE TO THE ADVIA CENTAUR XPT CA15-3 METHOD. A PATIENT CORRELATION STUDY WAS PERFORMED AT THE CUSTOMER SITE DURING THE TRANSITION; CUSTOMER OBSERVED ACCEPTABLE CORRELATION RESULTS. THE CUSTOMER THEN OBSERVED DISCORDANT LOW ADVIA CENTAUR XPT CA15-3 RESULTS WHEN THEY BEGAN REPORTING PATIENT RESULTS. THE CUSTOMER PROVIDED ATELLICA IM CA15-3 RESULTS FOR TROUBLESHOOTING. THE CUSTOMER IS NOT QUESTIONING THE ATELLICA IM CA15-3 RESULTS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA15-3 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950968 ↗
• MalfunctionApr 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER IS QUESTIONING ADVIA CENTAUR XPT CA15-3 RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH ONE REAGENT LOT. THIS CUSTOMER TRANSITIONED FROM IMMULITE TO THE ADVIA CENTAUR XPT CA15-3 METHOD. A PATIENT CORRELATION STUDY WAS PERFORMED AT THE CUSTOMER SITE DURING THE TRANSITION; CUSTOMER OBSERVED ACCEPTABLE CORRELATION RESULTS. THE CUSTOMER THEN OBSERVED DISCORDANT LOW ADVIA CENTAUR XPT CA15-3 RESULTS WHEN THEY BEGAN REPORTING PATIENT RESULTS. THE CUSTOMER PROVIDED ATELLICA IM CA15-3 RESULTS FOR TROUBLESHOOTING. THE CUSTOMER IS NOT QUESTIONING THE ATELLICA IM CA15-3 RESULTS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA15-3 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950967 ↗
• MalfunctionApr 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER IS QUESTIONING ADVIA CENTAUR XPT CA15-3 RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH ONE REAGENT LOT. THIS CUSTOMER TRANSITIONED FROM IMMULITE TO THE ADVIA CENTAUR XPT CA15-3 METHOD. A PATIENT CORRELATION STUDY WAS PERFORMED AT THE CUSTOMER SITE DURING THE TRANSITION; CUSTOMER OBSERVED ACCEPTABLE CORRELATION RESULTS. THE CUSTOMER THEN OBSERVED DISCORDANT LOW ADVIA CENTAUR XPT CA15-3 RESULTS WHEN THEY BEGAN REPORTING PATIENT RESULTS. THE CUSTOMER PROVIDED ATELLICA IM CA15-3 RESULTS FOR TROUBLESHOOTING. THE CUSTOMER IS NOT QUESTIONING THE ATELLICA IM CA15-3 RESULTS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA15-3 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950966 ↗
• MalfunctionApr 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER IS QUESTIONING ADVIA CENTAUR XPT CA15-3 RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH ONE REAGENT LOT. THIS CUSTOMER TRANSITIONED FROM IMMULITE TO THE ADVIA CENTAUR XPT CA15-3 METHOD. A PATIENT CORRELATION STUDY WAS PERFORMED AT THE CUSTOMER SITE DURING THE TRANSITION; CUSTOMER OBSERVED ACCEPTABLE CORRELATION RESULTS. THE CUSTOMER THEN OBSERVED DISCORDANT LOW ADVIA CENTAUR XPT CA15-3 RESULTS WHEN THEY BEGAN REPORTING PATIENT RESULTS. THE CUSTOMER PROVIDED ATELLICA IM CA15-3 RESULTS FOR TROUBLESHOOTING. THE CUSTOMER IS NOT QUESTIONING THE ATELLICA IM CA15-3 RESULTS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA15-3 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950965 ↗
• MalfunctionApr 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER IS QUESTIONING ADVIA CENTAUR XPT CA19-9 RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH ONE REAGENT LOT. THIS CUSTOMER TRANSITIONED FROM IMMULITE TO THE ADVIA CENTAUR XPT CA19-9 METHOD. A PATIENT CORRELATION STUDY WAS PERFORMED AT THE CUSTOMER SITE DURING THE TRANSITION; CUSTOMER OBSERVED ACCEPTABLE CORRELATION RESULTS. THE CUSTOMER THEN OBSERVED DISCORDANT LOW ADVIA CENTAUR XPT CA19-9 RESULTS WHEN THEY BEGAN REPORTING PATIENT RESULTS. THE CUSTOMER PROVIDED ATELLICA IM CA19-9 RESULTS FOR TROUBLESHOOTING. THE CUSTOMER IS NOT QUESTIONING THE ATELLICA IM CA19-9 RESULTS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950942 ↗
• MalfunctionApr 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER IS QUESTIONING ADVIA CENTAUR XPT CA19-9 RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH ONE REAGENT LOT. THIS CUSTOMER TRANSITIONED FROM IMMULITE TO THE ADVIA CENTAUR XPT CA19-9 METHOD. A PATIENT CORRELATION STUDY WAS PERFORMED AT THE CUSTOMER SITE DURING THE TRANSITION; CUSTOMER OBSERVED ACCEPTABLE CORRELATION RESULTS. THE CUSTOMER THEN OBSERVED DISCORDANT LOW ADVIA CENTAUR XPT CA19-9 RESULTS WHEN THEY BEGAN REPORTING PATIENT RESULTS. THE CUSTOMER PROVIDED ATELLICA IM CA19-9 RESULTS FOR TROUBLESHOOTING. THE CUSTOMER IS NOT QUESTIONING THE ATELLICA IM CA19-9 RESULTS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950941 ↗
• MalfunctionApr 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER IS QUESTIONING ADVIA CENTAUR XPT CA19-9 RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH ONE REAGENT LOT. THIS CUSTOMER TRANSITIONED FROM IMMULITE TO THE ADVIA CENTAUR XPT CA19-9 METHOD. A PATIENT CORRELATION STUDY WAS PERFORMED AT THE CUSTOMER SITE DURING THE TRANSITION; CUSTOMER OBSERVED ACCEPTABLE CORRELATION RESULTS. THE CUSTOMER THEN OBSERVED DISCORDANT LOW ADVIA CENTAUR XPT CA19-9 RESULTS WHEN THEY BEGAN REPORTING PATIENT RESULTS. THE CUSTOMER PROVIDED ATELLICA IM CA19-9 RESULTS FOR TROUBLESHOOTING. THE CUSTOMER IS NOT QUESTIONING THE ATELLICA IM CA19-9 RESULTS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950940 ↗
• MalfunctionApr 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER IS QUESTIONING ADVIA CENTAUR XPT CA19-9 RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH ONE REAGENT LOT. THIS CUSTOMER TRANSITIONED FROM IMMULITE TO THE ADVIA CENTAUR XPT CA19-9 METHOD. A PATIENT CORRELATION STUDY WAS PERFORMED AT THE CUSTOMER SITE DURING THE TRANSITION; CUSTOMER OBSERVED ACCEPTABLE CORRELATION RESULTS. THE CUSTOMER THEN OBSERVED DISCORDANT LOW ADVIA CENTAUR XPT CA19-9 RESULTS WHEN THEY BEGAN REPORTING PATIENT RESULTS. THE CUSTOMER PROVIDED ATELLICA IM CA19-9 RESULTS FOR TROUBLESHOOTING. THE CUSTOMER IS NOT QUESTIONING THE ATELLICA IM CA19-9 RESULTS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950939 ↗
• MalfunctionApr 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER IS QUESTIONING ADVIA CENTAUR XPT CA19-9 RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED WITH ONE REAGENT LOT. THIS CUSTOMER TRANSITIONED FROM IMMULITE TO THE ADVIA CENTAUR XPT CA19-9 METHOD. A PATIENT CORRELATION STUDY WAS PERFORMED AT THE CUSTOMER SITE DURING THE TRANSITION; CUSTOMER OBSERVED ACCEPTABLE CORRELATION RESULTS. THE CUSTOMER THEN OBSERVED DISCORDANT LOW ADVIA CENTAUR XPT CA19-9 RESULTS WHEN THEY BEGAN REPORTING PATIENT RESULTS. THE CUSTOMER PROVIDED ATELLICA IM CA19-9 RESULTS FOR TROUBLESHOOTING. THE CUSTOMER IS NOT QUESTIONING THE ATELLICA IM CA19-9 RESULTS. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950938 ↗
• MalfunctionMar 31, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ADVIA CENTAUR XPT CA 15-3 RESULT WAS OBTAINED ON PATIENT SAMPLE. THE CUSTOMER PERFORMED REPEAT TESTING ON AN ATELLICA IM SYSTEM, RESULTING LOWER. THE LOWER CA 15-3 REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT CA 15-3 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9908170 ↗
• MalfunctionSep 30, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT LOW ADVIA CENTAUR XPT CA 15-3 RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED, AND THE RESULT WAS HIGH. ANOTHER SAMPLE FROM THE SAME PATIENT WAS TESTED AND THE RESULT WAS HIGH. THE INITIAL LOW RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE FINAL RESULT REPORTED TO THE PHYSICIAN WAS THE RESULT OF 147 U/ML. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 15-3 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9137855 ↗