ADVIA Centaur® HBsAg 10309057Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414472867), received between Aug 4, 2017 and Feb 11, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2022False Negative Result; False Negative Result

  CUSTOMER OBSERVED FALSE NEGATIVE RESULTS FROM A SAMPLE WITH ADVIA CENTAUR CP HBSAG (HBS) ASSAY ON COMPARISON WITH INITIAL REACTIVE RESULTS FROM THE SAME SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER ADVIA CENTAUR CP BECAUSE THE INITIAL RESULT WAS POSITIVE AND THE PATIENT'S PREVIOUS RESULT FROM (B)(6) 2021 WAS NEGATIVE FOR HBS. THE NEGATIVE RESULTS WERE REPORTED TO THE PHYSICIAN WHO DID NOT QUESTION THE RESULTS. THE CONFIRMED POSITIVE RESULTS WERE CONSIDERED THE CORRECT RESULT AND WERE SENT OUT AS CORRECTED RESULTS. THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR POSTPONED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSE NEGATIVE ADVIA CENTAUR CP HBS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514835 ↗
• MalfunctionJul 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE USING THE ADVIA CENTAUR CP HBSAG (HBS) ASSAY. THE INITIAL RESULT WAS (B)(6). THE SAME SAMPLE WAS RETESTED AND A (B)(6) RESULT WAS OBTAINED. THESE RESULTS WERE CONSIDERED DISCORDANT BY THE CUSTOMER. THE SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND A (B)(6) RESULT WAS OBTAINED. THE (B)(6) RESULT WAS ACCEPTED BY THE PHYSICIAN. ADDITIONAL CLINICAL DIAGNOSTIC TESTS WERE PERFORMED BY THE CUSTOMER. CONTROLS WERE ALL WITHIN THE NORMAL RANGES. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DUE TO THE DISCORDANT HBSAG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8778228 ↗
• MalfunctionMar 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) ADVIA CENTAUR XP HBSAG (HBS) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PHYSICIAN QUESTIONED THE RESULTS. THE PATIENT SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP HBSAGII ASSAY AND THE RESULTS WERE (B)(6). THE SAMPLE WAS THEN MANUALLY DILUTED WITH NEGATIVE SERUM AND TESTED WITH HBSAGII ASSAY AND THE RESULTS WERE (B)(6). A CORRECTED REPORT WAS ISSUED. THE DILUTED (B)(6) RESULTS WERE ACCEPTED BY THE PHYSICIAN. THE PATIENT IS A HOSPITAL PATIENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HBSAG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8456929 ↗
• MalfunctionAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) ADVIA CENTAUR XP HBSAG (HBS) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED (B)(6) COMPARED TO ALTERNATE HBSAG TEST METHOD RESULTS. THE CUSTOMER PERFORMED REPEAT ADVIA CENTAUR XP HBSAG TESTING OF THE PATIENT SAMPLE AND THE RESULT WAS (B)(6). THE SAMPLE WAS TESTED ON TWO OTHER ALTERNATE HBSAG TEST METHODS, AND THE RESULTS WERE (B)(6). THE PATIENT SAMPLE WAS DILUTED WITH SALINE, AND THE ADVIA CENTAUR XP HBSAG RESULT WAS (B)(6). A (B)(6) RESULT WAS REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XP HBSAG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6768384 ↗