ADVIA Centaur® aHBs2 10698706Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00630414591407), received between Nov 9, 2018 and May 16, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “False Positive 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A REACTIVE (POSITIVE) ADVIA CENTAUR ANTI-HBS2 (AHBS2) RESULT FOR ONE PATIENT SAMPLE WHEN USING LOT 165 WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING USING ANOTHER REAGENT LOT. AN INITIAL STRONGLY REACTIVE RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION USING AHBS2 LOT 165; THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED TWICE USING REAGENT LOT 160, PRODUCING CONSISTENT NONREACTIVE (NEGATIVE) RESULTS. THE NONREACTIVE RESULTS WERE CONSIDERED CORRECT, AS THEY WERE IN AGREEMENT WITH THE CLINICAL PICTURE FOR THIS PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332234 ↗
• MalfunctionNov 11, 2021False Positive Result; False Positive Result

  A (B)(6) ADVIA CENTAUR XP (B)(6) RESULT INTERPRETATION WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED TO BE DISCORDANT COMPARED TO A (B)(6) RESULT INTERPRETATION WHEN TESTED ON AN ALTERNATE ADVIA CENTAUR XP SYSTEM. THE CUSTOMER PERFORMED REPEAT TESTING OF THE SAME SAMPLE ON THE ORIGINAL ADVIA CENTAUR XP SYSTEM (SN (B)(4)), RESULTING (B)(6). THE SAME SAMPLE WAS TESTED A SECOND TIME ON THE SAME ALTERNATE ADVIA CENTAUR XP SYSTEM ((B)(4)) WITH A (B)(6) RESULT INTERPRETATION. A (B)(6) RESULT WAS REPORTED TO THE PROVIDER(S) AS THE CORRECT RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, ADVIA CENTAUR XP (B)(6) RESULT INTERPRETATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800774 ↗
• MalfunctionJun 3, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON LOT 122. THE REPEAT RESULTS RUN WITH LOT 122 WERE (B)(6). THIS SAMPLE WAS REPEATED WITH (B)(6) LOT 120 ON ANOTHER ADVIA CENTAUR XP SYSTEM, AND THE RESULTS WERE (B)(6). THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10115643 ↗
• MalfunctionMay 28, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A REACTIVE (POSITIVE) ADVIA CENTAUR XP (B)(6) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT MISTAKENLY RETURNED FOR (B)(6) TESTING ON (B)(6) 2020 AND THE RESULT WAS NONREACTIVE (NEGATIVE). THE PHYSICIAN QUESTIONED THE RESULTS. IT IS UNKNOWN WHICH IS THE CORRECT RESULT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10097029 ↗
• MalfunctionMay 31, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE REACTIVE ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED WITH A DIFFERENT REAGENT LOT (LOT # 106) AND THE RESULTS WERE NEGATIVE. THE PATIENT SAMPLE WAS REPEATED WITH THE INITAL REAGENT LOT (LOT # 104) AND THE RESULTS WERE POSITIVE. THE INITIAL POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND THE RESULT 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 ANTI-HBS2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8657999 ↗
• MalfunctionMay 31, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE REACTIVE ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED WITH A DIFFERENT REAGENT LOT (LOT # 106) AND THE RESULTS WERE NEGATIVE. THE PATIENT SAMPLE WAS REPEATED WITH THE INITAL REAGENT LOT (LOT # 104) AND THE RESULTS WERE POSITIVE. THE INITIAL POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND THE RESULT 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 ANTI-HBS2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8657995 ↗
• MalfunctionMay 31, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED WITH A DIFFERENT REAGENT LOT (LOT # 106) AND THE RESULTS WERE (B)(6). THE PATIENT SAMPLE WAS REPEATED WITH THE INITAL REAGENT LOT (LOT # 104) AND THE RESULTS WERE (B)(6). THE INITIAL (B)(6) RESULT WAS REPORTED TO THE PHYSICIAN AND THE RESULT 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 ANTI-HBS2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8657991 ↗
• MalfunctionMay 31, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE REACTIVE ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED WITH A DIFFERENT REAGENT LOT (LOT # 106) AND THE RESULTS WERE NEGATIVE. THE PATIENT SAMPLE WAS REPEATED WITH THE INITAL REAGENT LOT (LOT # 104) AND THE RESULTS WERE POSITIVE. THE INITIAL POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND THE RESULT 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 ANTI-HBS2 RESULTS.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 8657990 ↗
• MalfunctionApr 26, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED AN ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULT THAT WAS ELEVATED AND (B)(6) AND DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. THE PHYSICIAN QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP AHBS2 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8554625 ↗
• MalfunctionApr 26, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED AN ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULT THAT WAS ELEVATED AND (B)(6) AND DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. THE PHYSICIAN QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP AHBS2 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8554623 ↗
• MalfunctionApr 19, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE INITIAL RESULT FOR THE SAMPLE WAS IN THE RETEST ZONE. THE SAMPLE WAS REPEATED IN DUPLICATE. ONE RESULT WAS (B)(6) AND THE SECOND RESULT WAS (B)(6) WITH THE FINAL INTERPRETATION AS (B)(6). A SECOND SAMPLE FOR THE SAME PATIENT WAS RUN. ONE RESULT WAS IN THE RETEST ZONE AND ONE RESULT WAS (B)(6). THE (B)(6) RESULT WAS REPORTED. ANOTHER EDTA PLASMA TUBE WAS TESTED AND THE RESULT WAS (B)(6). THE LABORATORY RECEIVED ANOTHER DRAW FOR THE SAME PATIENT TWO WEEKS LATER. THE SAMPLE WAS TESTED FOR (B)(6) AND THE RESULT WAS (B)(6). PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8531708 ↗
• MalfunctionMar 29, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER WAS CONCERNED ABOUT (B)(6) RESULTS OBTAINED FOR ONE PATIENT THAT WAS TESTED USING ADVIA CENTAUR XP ANTI-HBS2 (AHBS2). CLINICAL HISTORY OF THE PATIENT IS UNKNOWN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE IS NO REPORT OF ADVERSE HEALTH CONSEQUENCE DUE TO THE ADVIA CENTAUR XP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466283 ↗
• MalfunctionNov 9, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE REACTIVE ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. A NEW SAMPLE WAS TESTED AND THE RESULT WAS NONREACTIVE. THE NEW SAMPLE WAS REPEATED AND THE RESULT WAS NONREACTIVE. THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS NONREACTIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ANTI-HBS2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8054607 ↗