ADVIA Centaur® aHBs2 10286268Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00630414561790), received between Feb 20, 2018 and Feb 1, 2023 — classified as 68 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (20 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 24, 2020False Positive Result; False Positive Result

  DISCORDANT, (B)(6) ADVIA CENTAUR XP 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 (B)(6) BECAUSE THE PATIENT HAD PREVIOUSLY (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 10580553 ↗
• MalfunctionAug 19, 2020False Positive Result; False Positive Result

  A (B)(6) ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) RESULT WAS OBTAINED BY THE CUSTOMER AND REPORTED TO THE PHYSICIAN(S). THE (B)(6) RESULT WAS CONSIDERED DISCORDANT COMPARED TO A REPEAT (B)(6) ANTI-HBS2 RESULT. THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAMPLES FROM THIS PATIENT AND THE RESULTS WERE (B)(6). THE (B)(6) 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, (B)(6) ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10424844 ↗
• MalfunctionAug 5, 2020False Positive Result; False Positive Result

  FALSE POSITIVE ADVIA CENTAUR XPT (B)(6) RESULTS WERE OBTAINED BY THE CUSTOMER ON THE SAME PATIENT AND CONSIDERED DISCORDANT COMPARED TO A NEGATIVE ALTERNATE (B)(6) TEST METHOD RESULT. THE NEGATIVE ALTERNATE (B)(6) TEST METHOD 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 ADVIA CENTAUR XPT (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10370713 ↗
• MalfunctionAug 5, 2020False Positive Result; False Positive Result

  FALSE POSITIVE ADVIA CENTAUR XPT (B)(6) RESULTS WERE OBTAINED BY THE CUSTOMER ON THE SAME PATIENT AND CONSIDERED DISCORDANT COMPARED TO A NEGATIVE ALTERNATE (B)(6) TEST METHOD RESULT. THE NEGATIVE ALTERNATE (B)(6) TEST METHOD 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 ADVIA CENTAUR XPT (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10370710 ↗
• MalfunctionAug 5, 2020False Positive Result; False Positive Result

  (B)(6) ADVIA CENTAUR XPT (B)(6) RESULTS WERE OBTAINED BY THE CUSTOMER ON THE SAME PATIENT AND CONSIDERED (B)(6) COMPARED TO A (B)(6) ALTERNATE (B)(6) TEST METHOD RESULT. THE (B)(6) ALTERNATE (B)(6) TEST METHOD 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 (B)(6) ADVIA CENTAUR XPT (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10370709 ↗
• MalfunctionJul 23, 2020False Positive Result; False Positive Result

  (B)(6) ADVIA CENTAUR XPT (B)(6) RESULTS WERE OBTAINED BY THE CUSTOMER ON THE SAME PATIENT AND CONSIDERED DISCORDANT COMPARED TO A (B)(6) ALTERNATE (B)(6) TEST METHOD RESULT. THE NONREACTIVE ALTERNATE (B)(6) TEST METHOD RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XPT (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10317319 ↗
• MalfunctionFeb 24, 2020No Apparent Adverse Event; No Apparent Adverse Event

  (B)(6) ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULTS WERE OBTAINED BY THE CUSTOMER ON THE SAME PATIENT AND CONSIDERED DISCORDANT COMPARED TO A NEGATIVE ALTERNATE ANTI-HBS TEST METHOD RESULT. THE (B)(6) ALTERNATE ANTI-HBS TEST METHOD RESULT WAS REPORTED TO THE PHYSICIAN(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 ANTI-HBS2 (AHBS2) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9747055 ↗
• MalfunctionFeb 24, 2020No Apparent Adverse Event; No Apparent Adverse Event

  (B)(6) ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULTS WERE OBTAINED BY THE CUSTOMER ON THE SAME PATIENT AND (B)(6) NEGATIVE ALTERNATE ANTI-HBS TEST METHOD RESULT WAS REPORTED TO THE PHYSICIAN(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 ANTI-HBS2 (AHBS2) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9747043 ↗
• MalfunctionFeb 24, 2020No Apparent Adverse Event; No Apparent Adverse Event

  (B)(6) ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULTS WERE OBTAINED BY THE CUSTOMER ON THE SAME PATIENT AND CONSIDERED DISCORDANT COMPARED TO A (B)(6) ALTERNATE ANTI-HBS TEST METHOD RESULT. THE (B)(6) ALTERNATE ANTI-HBS TEST METHOD RESULT WAS REPORTED TO THE PHYSICIAN(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 ANTI-HBS2 (AHBS2) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9747041 ↗
• MalfunctionFeb 24, 2020No Apparent Adverse Event; No Apparent Adverse Event

  (B)(6) ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) RESULTS WERE OBTAINED BY THE CUSTOMER ON THE SAME PATIENT AND CONSIDERED DISCORDANT COMPARED TO A NEGATIVE ALTERNATE ANTI-HBS TEST METHOD RESULT. THE (B)(6) ALTERNATE ANTI-HBS TEST METHOD RESULT WAS REPORTED TO THE PHYSICIAN(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 ANTI-HBS2 (AHBS2) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9747035 ↗
• MalfunctionDec 16, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER OBTAINED DISCORDANT POSITIVE ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) PATIENT RESULTS COMPARED TO THE CLINICAL PICTURE, OTHER CLINICAL DIAGNOSTIC TEST RESULTS AS WELL AS TO THE ATELLICA IM AHBS2 ASSAY. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT AHBS2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9472722 ↗
• MalfunctionSep 26, 2019False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  A CUSTOMER OBTAINED DISCORDANT ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) PATIENT RESULTS FROM ONE PATIENT AS COMPARED TO AN ALTERNATE METHOD. THE PATIENT SAMPLE WAS INITIALLY TESTED ON (B)(6) 2019 WITH THE ADVIA CENTAUR XPT AHBS2 ASSAY. OTHER CLINICAL DIAGNOSTIC TESTS WERE ALSO PERFORMED, INCLUDING ALTERNATE TEST METHODS. A (B)(6) RESULT WAS OBTAINED WITH THE ADVIA CENTAUR XPT AHBS2 ASSAY, WHICH WAS DISCORDANT COMPARED TO THE RESULT OF THE ALTERNATE AHBS METHOD. THE SAMPLE WAS RETESTED ON (B)(6) 2019 AND A (B)(6) ADVIA CENTAUR XPT AHBS2 RESULT WAS OBTAINED AGAIN. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN. RESULTS REPORT WAS ISSUED BASED ON THE ALTERNATE METHOD AHBS RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT AHBS2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9126445 ↗