ADVIA Centaur aHBs2Recalls & reported problems across all models

We found 2 models of ADVIA Centaur aHBs2 by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between Feb 20, 2018 and May 16, 2024 — classified as 81 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ADVIA Centaur aHBs2 problems

ADVIA Centaur aHBs2 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ADVIA Centaur® aHBs2 10286268

  Qualitative and Quantitative Hepatitis B Virus Antibody assays
  68 reports
• ADVIA Centaur® aHBs2 10698706

  Qualitative and Quantitative Hepatitis B Virus Antibody assays
  13 reports

Recent ADVIA Centaur aHBs2 adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionFeb 1, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF A POSITIVE (REACTIVE) ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT TEST RESULTS AND CLINICAL INDICATIONS. THE INITIAL RESULT WAS REPORTED TO PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED ON THE SAME ATELLICA IM ANALYZER, AND THE RESULT WAS NEGATIVE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AHBS2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277126 ↗
• MalfunctionAug 22, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REPRODUCIBLY POSITIVE (REACTIVE) ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO ALTERNATE TEST RESULTS AND CLINICAL INDICATIONS. REPEAT TESTING USING ANOTHER ADVIA CENTAUR XP ANALYZER PRODUCED A SIMILAR (REACTIVE) RESULT. THE SAMPLE WAS SENT TO AN EXTERNAL LAB, WHERE IT WAS TESTED USING AN ALTERNATE PLATFORM, PRODUCING A NEGATIVE RESULT. THE NEGATIVE RESULTS WERE ACCEPTED AS CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAY OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271872 ↗
• MalfunctionAug 22, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REPRODUCIBLY POSITIVE (REACTIVE) ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO ALTERNATE TEST RESULTS AND CLINICAL INDICATIONS. REPEAT TESTING USING ANOTHER ADVIA CENTAUR XP ANALYZER PRODUCED A SIMILAR (REACTIVE) RESULT. THE SAMPLE WAS SENT TO AN EXTERNAL LAB, WHERE IT WAS TESTED USING AN ALTERNATE PLATFORM, PRODUCING A NEGATIVE RESULT. THE NEGATIVE RESULTS WERE ACCEPTED AS CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAY OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271825 ↗
• MalfunctionMar 25, 2022High Test Results; High Test Results

  CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR XPT ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT FOR A PATIENT SAMPLE COMPARED TO THE REPEAT RESULT. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED ADVIA CENTAUR AHBS2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13901582 ↗
• 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 2, 2021False Positive Result; False Positive Result

  A CUSTOMER OBSERVED (B)(6) ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) RESULTS ON A PATIENT SAMPLE, WHICH WERE CONSIDERED (B)(6) WHEN COMPARED TO OTHER (B)(6) TESTING. THE INITIAL RESULT WAS (B)(6). THE CUSTOMER PERFORMED REPEAT TESTING ON A DIFFERENT DAY WITH THE SAME REAGENT LOT NUMBER AND A (B)(6) RESULT WAS OBTAINED. THE SAMPLE WAS ALSO TESTED WITH A DIFFERENT REAGENT LOT AND A (B)(6) RESULT WAS OBTAINED. THE CUSTOMER SENT THE SAMPLE TO A DIFFERENT LABORATORY FOR VERIFICATION PURPOSES AND A (B)(6) RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922510 ↗
• MalfunctionJun 2, 2021False Positive Result; False Positive Result

  A CUSTOMER OBSERVED (B)(6) ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) RESULTS ON A PATIENT SAMPLE, WHICH WERE CONSIDERED DISCORDANT WHEN COMPARED TO OTHER (B)(6) TESTING. THE INITIAL RESULT WAS (B)(6). THE CUSTOMER PERFORMED REPEAT TESTING ON A DIFFERENT DAY WITH THE SAME REAGENT LOT NUMBER AND A (B)(6) RESULT WAS OBTAINED. THE SAMPLE WAS ALSO TESTED WITH A DIFFERENT REAGENT LOT AND A (B)(6) RESULT WAS OBTAINED. THE CUSTOMER SENT THE SAMPLE TO A DIFFERENT LABORATORY FOR VERIFICATION PURPOSES AND A (B)(6) RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922506 ↗
• MalfunctionJun 2, 2021False Positive Result; False Positive Result

  A CUSTOMER OBSERVED A (B)(6) ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) INITIAL PATIENT RESULT, WHICH WAS CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT TESTING AND OTHER (B)(6) TESTING. REPEAT TESTING WAS PERFORMED ON A DIFFERENT DAY WITH THE SAME REAGENT LOT NUMBER AND A (B)(6) RESULT WAS OBTAINED. THE SAMPLE WAS ALSO TESTED WITH A DIFFERENT REAGENT LOT AND (B)(6) RESULTS WERE OBTAINED. THE CUSTOMER SENT THE SAMPLE TO A DIFFERENT LABORATORY FOR VERIFICATION PURPOSES AND A (B)(6) RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922504 ↗
• MalfunctionJun 2, 2021False Positive Result; False Positive Result

  A CUSTOMER OBSERVED (B)(6) ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) RESULTS ON A PATIENT SAMPLE, WHICH WERE CONSIDERED DISCORDANT WHEN COMPARED TO OTHER (B)(6) TESTING. THE INITIAL RESULT WAS (B)(6). THE CUSTOMER PERFORMED REPEAT TESTING ON A DIFFERENT DAY WITH THE SAME REAGENT LOT NUMBER AND A (B)(6) RESULT WAS OBTAINED. THE SAMPLE WAS ALSO TESTED WITH A DIFFERENT REAGENT LOT AND A (B)(6) RESULT WAS OBTAINED. THE CUSTOMER SENT THE SAMPLE TO A DIFFERENT LABORATORY FOR VERIFICATION PURPOSES AND A (B)(6) RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922501 ↗
• MalfunctionMay 27, 2021False Positive Result; False Positive Result

  A CUSTOMER OBSERVED FALSE REACTIVE (POSITIVE) ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) RESULTS ON THE SAME DAY FOR SERUM SAMPLES FROM DIFFERENT PATIENTS. THE RESULTS WERE CONSIDERED DISCORDANT COMPARED TO THE RESULTS OBTAINED USING EDTA PLASMA SAMPLES FROM THE SAME PATIENTS. THE INITIAL RESULTS WERE NOT PROVIDED TO PHYSICIAN(S). THE CUSTOMER INDICATED THAT THE EDTA PLASMA SAMPLE RESULTS MATCHED WITH THE CLINICAL BACKGROUND OF THE PATIENTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AHBS2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897315 ↗
• MalfunctionMay 20, 2021False Positive Result; False Positive Result

  DISCORDANT, FALSE POSITIVE ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) RESULTS WERE OBTAINED BY THE CUSTOMER ON A PRIMARY SERUM SAMPLE TUBE. WHEN REPEATED, THE POSITIVE RESULT WAS CONSIDERED DISCORDANT COMPARED TO A NEGATIVE ANTI-HBS2 RESULT OBTAINED FROM A SECONDARY EDTA SAMPLE TUBE. THE NEGATIVE RESULT MATCHED WITH PATIENT HISTORY AND OTHER CLINICAL OBSERVATIONS. THE NEGATIVE ANTI-HBS2 RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, POSITIVE ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854532 ↗
• MalfunctionApr 15, 2021False Positive Result; False Positive Result

  A (B)(6) ADVIA CENTAUR XPT (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED TO BE DISCORDANT COMPARED TO A (B)(6) HISTORICAL RESULT FROM A YEAR AGO. THE CUSTOMER PERFORMED REPEAT TESTING OF THE SAMPLE ON THE SAME ADVIA CENTAUR XPT (1) SYSTEM, ALL RESULTING (B)(6). THE SAME SAMPLE WAS TESTED ON AN ALTERNATE ADVIA CENTAUR XPT (2) SYSTEM WITH A NEW REAGENT READYPACK, RESULTING (B)(6) (RETEST ZONE). DUE TO INSUFFICIENT SAMPLE VOLUME, THE CUSTOMER WAS NOT ABLE TO PERFORM DUPLICATE TESTING TO VERIFY THE (B)(6) RETEST ZONE RESULT. BASED ON THE PATIENT'S CLINICAL HISTORY, A (B)(6) RETEST ZONE RESULT AND THAT THE FACT THAT THE PATIENT WAS NOT VACCINATED FOR (B)(6), 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 XPT (B)(6) AND RETEST ZONE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675845 ↗
• MalfunctionApr 15, 2021False Positive Result; False Positive Result

  A (B)(6) ADVIA CENTAUR XPT (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED TO BE (B)(6) COMPARED TO A (B)(6) HISTORICAL RESULT FROM A YEAR AGO. THE CUSTOMER PERFORMED REPEAT TESTING OF THE SAMPLE ON THE SAME ADVIA CENTAUR XPT (1) SYSTEM, ALL RESULTING (B)(6). THE SAME SAMPLE WAS TESTED ON AN ALTERNATE ADVIA CENTAUR XPT (2) SYSTEM WITH A NEW REAGENT READYPACK, RESULTING (B)(6). DUE TO INSUFFICIENT SAMPLE VOLUME, THE CUSTOMER WAS NOT ABLE TO PERFORM DUPLICATE TESTING TO VERIFY THE (B)(6) RESULT. BASED ON THE PATIENT'S CLINICAL HISTORY, A (B)(6) RESULT AND THAT THE PATIENT WAS NOT VACCINATED FOR (B)(6), 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 XPT (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675805 ↗
• MalfunctionSep 24, 2020False Positive Result; False Positive Result

  DISCORDANT, FALSE POSITIVE ADVIA CENTAUR XP (B)(6) RESULTS WERE OBTAINED ON TWO SAMPLES FROM THE SAME PATIENT. THE SAMPLES WERE DRAWN FROM THE PATIENT ON DIFFERENT DATES. EACH SAMPLE WAS TESTED THE DAY AFTER THE SAMPLE WAS DRAWN. THE DISCORDANT RESULTS WERE REPORTED AND WERE QUESTIONED BY THE PHYSICIAN. THE SAMPLES WERE NOT RETESTED, AND A CORRECTED REPORT WAS NOT ISSUED. THE CUSTOMER BELIEVES THE POSITIVE RESULTS TO BE FALSE POSITIVE BECAUSE THE PATIENT HAD PREVIOUSLY NEGATIVE (B)(6) SEROLOGICAL TEST RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED AND NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10580559 ↗

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