ADVIA Centaur® CA 125II 10310443Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00630414461298), received between Jul 25, 2017 and Nov 27, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Feb 21, 2018Class IITerminated

   Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.

   Z-1486-2018 · Root cause: Other · Recall details · FDA record ↗

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 27, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS AN OBSERVATION OF DISCORDANCE BETWEEN RESULTS FROM NEAT (UNDILUTED) AND DILUTED SAMPLES WHEN RUNNING ADVIA CENTAUR CA 125II, LOT 219. DISCORDANCE WAS OBSERVED AMONG RESULTS FOR A 69-YEAR-OLD FEMALE PATIENT WITH OVARIAN CANCER. A CA 125II RESULT OF 541 U/ML WAS OBTAINED FOR THE PATIENT IN QUESTION, WHICH WAS CONSISTENT WITH THE PATIENT¿S RECENT TESTING IN (B)(6) 2024. WHEN THE SAMPLE WAS RE-TESTED, A RESULT OF 600 U/ML (ABOVE MEASURING RANGE) WAS OBTAINED. THE SAME SAMPLE WAS RE-TESTED AND OBTAINED SAME RESULT. WHEN THIS SAMPLE WAS REPEATED FOLLOWING 10-FOLD DILUTION, A MUCH HIGHER RESULT WAS OBSERVED. THESE HIGHER RESULTS WERE INCONSISTENT WITH THE INITIAL RESULT AS WELL AS THE PATIENT¿S TESTING RESULTS IN (B)(6) 2024. TO INVESTIGATE THIS INCONSISTENCY, THE SAME SAMPLE WAS RE-TESTED ON AN ALTERNATE INSTRUMENT WHICH PRODUCED A NEAT (UNDILUTED) RESULT OF 576 U/ML, SIMILAR TO THE INITIAL RESULT AND WHEN REPEATED FOLLOWING 10-FOLD DILUTION, A MUCH HIGHER RESULT WAS PRODUCED, SIMILAR TO THE PREVIOUS DILUTED RESULT. THIS SAMPLE ALSO PRODUCED SIMILAR HIGHER RESULTS FOLLOWING 2-FOLD AND 10-FOLD MANUAL DILUTIONS. THE INITIAL RESULT IS CONSIDERED TO BE CORRECT, AND THE H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797781 ↗
• MalfunctionApr 1, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT LOW ADVIA CENTAUR XPT CA 125II REPEAT RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS INITIALLY TESTED ON AN ATELLICA IM SYSTEM FOR CA 125II THAT RESULTED HIGHER. THE FOLLOWING DAY, THE SAME PATIENT SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR XPT SYSTEM AND THE RESULT WAS SIMILAR TO THE HIGHER ATELLICA CA 125II RESULT. THE HIGHER CA 125II 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 125II RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9910731 ↗
• MalfunctionFeb 20, 2020Low Test Results; No Apparent Adverse Event; Low Test Results; No Apparent Adverse Event

  A CUSTOMER OBTAINED A DISCORDANT LOW ADVIA CENTAUR XP CA 125 II RESULT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN BECAUSE A PREVIOUS RESULT FOR THE SAME PATIENT WAS HIGHER. THE SAME SAMPLE WAS RETESTED NEAT AND DILUTED. THE NEAT RESULT OBTAINED WAS SIMILAR TO THE INITIAL LOW RESULT, BUT THE DILUTION TESTING RESULTS WERE HIGHER. THE SAME SAMPLE WAS ALSO TESTED ON AN ALTERNATE METHOD AND A HIGH RESULT WAS OBTAINED. IT IS UNKNOWN IF RETEST RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 125 II RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9732660 ↗
• MalfunctionFeb 20, 2020Low Test Results; No Apparent Adverse Event; Low Test Results; No Apparent Adverse Event

  A CUSTOMER OBTAINED A DISCORDANT LOW ADVIA CENTAUR XP CA 125 II RESULT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN BECAUSE A PREVIOUS RESULT FOR THE SAME PATIENT WAS HIGHER. THE SAME SAMPLE WAS RETESTED NEAT AND DILUTED. THE NEAT RESULT OBTAINED WAS SIMILAR TO THE INITIAL LOW RESULT, BUT THE DILUTION TESTING RESULTS WERE HIGHER. THE SAME SAMPLE WAS ALSO TESTED ON AN ALTERNATE METHOD AND A HIGH RESULT WAS OBTAINED. IT IS UNKNOWN IF RETEST RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA125 II RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9732659 ↗
• MalfunctionMay 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT LOW ADVIA CENTAUR XP CA 125II RESULT WAS OBTAINED ON A PATIENT SAMPLE WHEN TESTED NEAT. THE PATIENT SAMPLE WAS REPEATED, AND THE VALUE WAS >600 U/ML. THE PATIENT SAMPLE WAS DILUTED AND THE RESULT WAS HIGHER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA125II RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8605288 ↗
• MalfunctionApr 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED A NEAT SAMPLE RESULT FOR ADVIA CENTAUR XP CA 125II THAT WAS LOW COMPARED TO DILUTED VALUES. THE PHYSICIAN QUESTIONED THE RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR XP CA 125II RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8551888 ↗
• MalfunctionNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LOW ADVIA CENTAUR XP CA 125II RESULT WAS OBTAINED ON A PATIENT SAMPLE, AND CONSIDERED DISCORDANT BY THE CUSTOMER WHEN COMPARED TO A HIGHER CA 125II HISTORICAL RESULT. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS LOW. THE SAME SAMPLE WAS DILUTED, AND A HIGHER CA 125II RESULT WAS OBTAINED. THERE ARE NO REPORTS THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR XP CA 125II RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7050784 ↗
• MalfunctionSep 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A COMPARISON STUDY WITH A NEW LOT OF ADVIA CENTAUR XP CA 125II, THE CUSTOMER NOTED A DIFFERENCE IN PATIENT SAMPLE RESULTS FOR TWO SAMPLES. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN ADVIA CENTAUR XP CA 125II RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861314 ↗
• MalfunctionSep 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A COMPARISON STUDY WITH A NEW LOT OF ADVIA CENTAUR XP CA 125II, THE CUSTOMER NOTED A DIFFERENCE IN PATIENT SAMPLE RESULTS FOR TWO SAMPLES. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN ADVIA CENTAUR XP CA 125II RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861306 ↗
• MalfunctionJul 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT LOW ADVIA CENTAUR XP CA 125II RESULT WAS OBTAINED ON A PATIENT SAMPLE UPON REPEAT AT A LATER DATE. THE PATIENT SAMPLE WAS REPEATED AFTER THE CUSTOMER CHANGED THE RANGE FROM 0-320 TO 2-600U/ML. THE SAMPLE WAS TESTED INITIALLY AND THE VALUE WAS >320. THE PATIENT SAMPLE WAS DILUTED AND THE RESULT WAS HIGHER. THIS RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. THE SAMPLE WAS REPEATED AGAIN AFTER THAWING. THE RESULTS WERE HIGHER. A REDRAW SAMPLE WAS TESTED BY THE TECHNICAL APPLICATION SPECIALIST (TAS) AND THE RESULTS WERE HIGH. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA125II RESULT,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6739731 ↗