ADVIA Centaur® HBsAg Conf (Confirmatory) 10309058Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00630414472874), received between Mar 6, 2018 and Apr 10, 2020 — classified as 12 malfunctions.

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

• MalfunctionApr 10, 2020False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  A CUSTOMER OBTAINED AN ERRONEOUS RESULT OF "NOT CONFIRMED" USING ADVIA CENTAUR XP (B)(6) CONFIRMATORY ASSAY COMPARED TO PREVIOUS RESULTS ON THE SAME DAY AND A DIFFERENT DAY. THE CUSTOMER INDICATES THAT THE PATIENT IS CONSIDERED (B)(6) FOR (B)(6) INFECTION. THE ERRONEOUS RESULT OF "NOT CONFIRMED" WAS NOT REPORTED TO PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE NEGATIVE (B)(6) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950992 ↗
• MalfunctionFeb 28, 2020No Apparent Adverse Event; No Apparent Adverse Event

  ADVIA CENTAUR XP (B)(6) CONFIRMATORY NON CONFIRMED RESULTS WERE OBTAINED BY THE CUSTOMER ON PATIENT SAMPLES AND CONSIDERED DISCORDANT COMPARED TO POSITIVE (B)(6) RESULTS. THE POSITIVE (B)(6) RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED ADDITIONAL (B)(6) CONFIRMATORY TESTING THAT CONFIRMED THE POSITIVE (B)(6) TEST RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP (B)(6) CONFIRMATORY RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9770915 ↗
• MalfunctionFeb 28, 2020No Apparent Adverse Event; No Apparent Adverse Event

  ADVIA CENTAUR XP HBSAG CONFIRMATORY NON CONFIRMED RESULTS WERE OBTAINED BY THE CUSTOMER ON PATIENT SAMPLES AND CONSIDERED DISCORDANT COMPARED TO POSITIVE HBSAG RESULTS. THE POSITIVE HBSAG RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED ADDITIONAL HBSAG CONFIRMATORY TESTING THAT CONFIRMED THE POSITIVE HBSAG TEST RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HBSAG CONFIRMATORY RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9770910 ↗
• MalfunctionFeb 28, 2020No Apparent Adverse Event; No Apparent Adverse Event

  ADVIA CENTAUR XP (B)(6) CONFIRMATORY NON CONFIRMED RESULTS WERE OBTAINED BY THE CUSTOMER ON PATIENT SAMPLES AND CONSIDERED DISCORDANT COMPARED TO POSITIVE (B)(6) RESULTS. THE POSITIVE (B)(6) RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED ADDITIONAL (B)(6) CONFIRMATORY TESTING THAT CONFIRMED THE POSITIVE (B)(6) TEST RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP (B)(6) CONFIRMATORY RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9770907 ↗
• MalfunctionFeb 28, 2020No Apparent Adverse Event; No Apparent Adverse Event

  ADVIA CENTAUR XP HBSAG CONFIRMATORY NON CONFIRMED RESULTS WERE OBTAINED BY THE CUSTOMER ON PATIENT SAMPLES AND CONSIDERED DISCORDANT COMPARED TO (B)(6) RESULTS. THE (B)(6) RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED ADDITIONAL (B)(6) CONFIRMATORY TESTING THAT CONFIRMED THE (B)(6) TEST RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HBSAG CONFIRMATORY RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9770905 ↗
• MalfunctionFeb 28, 2020No Apparent Adverse Event; No Apparent Adverse Event

  ADVIA CENTAUR XP (B)(6) CONFIRMATORY NON CONFIRMED RESULTS WERE OBTAINED BY THE CUSTOMER ON PATIENT SAMPLES AND CONSIDERED DISCORDANT COMPARED TO (B)(6) RESULTS. THE (B)(6) RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED ADDITIONAL (B)(6) CONFIRMATORY TESTING THAT CONFIRMED THE (B)(6) TEST RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HBSAG CONFIRMATORY RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9770898 ↗
• MalfunctionFeb 28, 2020No Apparent Adverse Event; No Apparent Adverse Event

  ADVIA CENTAUR XP HBSAG CONFIRMATORY NON CONFIRMED RESULTS WERE OBTAINED BY THE CUSTOMER ON PATIENT SAMPLES AND CONSIDERED DISCORDANT COMPARED TO (B)(6) HBSAG RESULTS. THE (B)(6) HBSAG RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER PERFORMED ADDITIONAL HBSAG CONFIRMATORY TESTING THAT CONFIRMED THE (B)(6) HBSAG TEST RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HBSAG CONFIRMATORY RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9770895 ↗
• MalfunctionFeb 6, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER OBTAINED AN ERRONEOUS RESULT WITH THE ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY. A PATIENT WAS DIAGNOSED IN (B)(6) 2019 AS (B)(6) FOR (B)(6) INFECTION (RESULTS/METHOD UNKNOWN). ON (B)(6) 2019, A SAMPLE FROM THE PATIENT WAS TESTED WITH THE ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY AFTER HAVING OBTAINED A HIGH POSITIVE RESULT FOR ADVIA CENTAUR XP HBSAGII; A RESULT OF NOT CONFIRMED WAS OBTAINED. RESULT WAS REPORTED TO PHYSICIAN, WHO DID NOT QUESTION THE RESULT. A SECOND SAMPLE WAS DRAWN FROM THE SAME PATIENT ON (B)(6) 2020 AND WAS TESTED WITH THE ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY AFTER HAVING OBTAINED A HIGH POSITIVE RESULT FOR ADVIA CENTAUR XP HBSAGII; A RESULT OF NOT CONFIRMED WAS OBTAINED AGAIN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE NOT CONFIRMED ADVIA CENTAUR XP (B)(6) CONFIRMATORY RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9675951 ↗
• MalfunctionFeb 6, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER OBTAINED AN ERRONEOUS RESULT WITH THE (B)(6) CONFIRMATORY (CONF) ASSAY. A PATIENT WAS DIAGNOSED IN (B)(6) 2019 AS (B)(6) FOR (B)(6) INFECTION (RESULTS/METHOD UNKNOWN). ON (B)(6) 2019, A SAMPLE FROM THE PATIENT WAS TESTED WITH THE (B)(6) CONFIRMATORY (CONF) ASSAY AFTER HAVING OBTAINED A HIGH (B)(6) RESULT FOR (B)(6); A RESULT OF NOT CONFIRMED WAS OBTAINED. RESULT WAS REPORTED TO PHYSICIAN, WHO DID NOT QUESTION THE RESULT. A SECOND SAMPLE WAS DRAWN FROM THE SAME PATIENT ON (B)(6) 2020 AND WAS TESTED WITH THE (B)(6) CONFIRMATORY (CONF) ASSAY AFTER HAVING OBTAINED A HIGH (B)(6) RESULT FOR (B)(6); A RESULT OF NOT CONFIRMED WAS OBTAINED AGAIN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE NOT CONFIRMED (B)(6) CONFIRMATORY RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9675950 ↗
• MalfunctionOct 10, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A NON-CONFIRMED ADVIA CENTAUR XP HBSAG CONFIRMATORY RESULT WAS OBTAINED ON A PATIENT'S PLASMA (EDTA) SAMPLE, AND CONSIDERED DISCORDANT COMPARED TO A CONFIRMED ADVIA CENTAUR XP HBSAGII CONFIRMATORY SERUM SAMPLE RESULT. THE CUSTOMER PERFORMED REPEAT HBSAGII TESTING WITH A PLASMA SAMPLE DUE TO THE INITIALLY HBSAGII CONFIRMED REACTIVE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NON-CONFIRMED ADVIA CENTAUR XP HBSAG CONFIRMATORY PLASMA (EDTA) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7952939 ↗
• MalfunctionMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NOT CONFIRMED ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) RESULT WAS OBTAINED ON A PATIENT SAMPLE WHEN RUN WITH A DILUTION OF 50. THE RESULT WAS QUESTIONED SINCE THE NEAT TESTING WITH THE ADVIA CENTAUR XP HBSAG CONFIRMATORY WAS INVALID ON TWO SYSTEMS AND TESTING WITH THE (B)(6) ASSAY WAS REPEAT (B)(6). THE CUSTOMER SENT THE SAMPLE TO ANOTHER SITE FOR (B)(6) DNA TESTING AND THE RESULT WAS (B)(6). PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) CONFIRMATORY RESULT..

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7520416 ↗
• MalfunctionMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) RESULT WAS OBTAINED ON A DILUTION (B)(6) PATIENT SAMPLE. THE CUSTOMER OBSERVED WITH A RE-DILUTE FLAG WHEN (B)(6) TESTING WAS INITIALLY PERFORMED, HOWEVER PRIOR TO DILUTING THE SAMPLE FOR (B)(6) TESTING, THE SAMPLE WAS RUN NEAT CONFIRMING THE (B)(6) RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(4) DILUTED (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7318836 ↗