ADVIA Centaur® HBsII 10492138Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00630414578170), received between Jun 14, 2018 and Aug 3, 2023 — classified as 18 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (10 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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ADVIA CENTAUR HBSAGII (HBSII) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. IN (B)(6) OF 2021, A PATIENT WAS TESTED FOR HEPATITIS B SURFACE ANTIGEN USING HBSII LOT 238, AND A RESULT OF 0.70 INDEX (NONREACTIVE) WAS OBTAINED AND REPORTED. IN (B)(6) OF 2023, THE PATIENT WAS TESTED FOR HEPATITIS FOLLOWING ABNORMAL LIVER FUNCTION TESTS. A RESULT OF >1000 WAS PRODUCED USING HBSII, AND THE SAMPLE WAS REFERRED FOR CONFIRMATORY TESTING. RESULTS CONFIRMED A HEPATITIS B INFECTION OF >3 MONTHS DURATION. PATIENT CLINICAL STATUS INDICATED LIKELY REACTIVATION OF A CHRONIC INFECTION, RATHER THAN AN ACUTE INFECTION. THE SAMPLE FROM (B)(6) OF 2021 WAS RE-TESTED USING AN ALTERNATE METHOD, PRODUCING A POSITIVE RESULT OF 1.3 INDEX. VIRAL-LOAD TESTING (HBV DNA BY PCR) WAS ALSO PERFORMED, WHICH PRODUCED A VERY LOW POSITIVE RESULT. THESE RETROSPECTIVE RESULTS INDICATE THAT THE INITIAL (0.7 INDEX) NEGATIVE HBSII RESULT WAS INCORRECT WHEN PRODUCED IN 2021. THERE ARE NO REPORTS OF ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453580 ↗
• MalfunctionJun 10, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED NONREACTIVE (NEGATIVE) ADVIA CENTAUR XPT HBSAGII (HBSII) RESULTS FOR A PATIENT SAMPLE THAT WERE CONSIDERED DISCORDANT WITH THE POSITIVE RESULT FROM AN ALTERNATE METHOD. IT IS UNCLEAR WHICH IS THE CORRECT RESULT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT HBSII RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658093 ↗
• MalfunctionJun 10, 2022False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED NONREACTIVE (NEGATIVE) ADVIA CENTAUR XPT HBSAGII (HBSII) RESULTS FOR A PATIENT SAMPLE THAT WERE CONSIDERED DISCORDANT WITH THE POSITIVE RESULT FROM AN ALTERNATE METHOD. THE PATIENT SAMPLE WAS TESTED MULTIPLE TIMES WITH THE ADVIA CENTAUR XPT HBSII ASSAY AND THE RESULTS OF THE REPLICATES VARIED BETWEEN REACTIVE (POSITIVE) AND NONREACTIVE (NEGATIVE). IT IS UNCLEAR WHICH IS THE CORRECT RESULT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT HBSII RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658046 ↗
• MalfunctionJan 6, 2022False Negative Result; False Negative Result

  A CUSTOMER REPORTED OBSERVATION OF A DISCORDANT (B)(6) HEPATITIS B SURFACE ANTIGEN RESULT WHEN USING THE ADVIA CENTAUR HBSAGII (HBSII) ASSAY. AN INITIAL REACTIVE HBSII RESULT WAS OBTAINED FOR ONE PATIENT, AND A REPEAT TEST WAS AGAIN (B)(6). CONFIRMATORY HBV TESTING INDICATED (B)(6) PATIENT STATUS, AS WELL. A THIRD HBSII TEST FOR THE SAME SAMPLE PRODUCED A (B)(6) RESULT, WHICH CONFLICTED WITH THE EARLIER TEST RESULTS. THE PATIENT RESULTS WERE NOT REPORTED, DUE TO THE OBSERVED AMBIGUITY AMONG RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) HBSAGII RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13180314 ↗
• MalfunctionNov 2, 2021False Negative Result; False Negative Result

  A CUSTOMER INFORMED SIEMENS HEALTHCARE DIAGNOSTICS THAT THEY OBTAINED A NON-REACTIVE (NEGATIVE) ADVIA CENTAUR XP HBSAGII (HBSII) RESULT FOR A (B)(6) FEMALE PATIENT ON (B)(6) 2021. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE RESULT DOES NOT MATCH THE PATIENT'S CLINICAL HISTORY, WHERE RESULTS HAVE BEEN REACTIVE SINCE 2016, EXCEPT FOR ONE OTHER INSTANCE IN 2020 WHERE A NON-REACTIVE RESULT WAS ALSO OBSERVED. REPEAT TESTING WAS PERFORMED USING AN ALTERNATE METHOD AND A REACTIVE (POSITIVE) RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (NON-REACTIVE) HBSAGII RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739542 ↗
• MalfunctionNov 2, 2021False Negative Result; False Negative Result

  A CUSTOMER INFORMED SIEMENS HEALTHCARE DIAGNOSTICS THAT THEY OBTAINED A (B)(6) ADVIA CENTAUR XP (B)(6) RESULT FOR A (B)(6) YEAR-OLD FEMALE PATIENT ON (B)(6) 2021. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE RESULT DOES NOT MATCH THE PATIENT'S CLINICAL HISTORY, WHERE RESULTS HAVE BEEN (B)(6) SINCE 2016, EXCEPT FOR ONE OTHER INSTANCE IN 2020 WHERE A (B)(6) RESULT WAS ALSO OBSERVED. REPEAT TESTING WAS PERFORMED USING AN ALTERNATE METHOD 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 12739539 ↗
• MalfunctionSep 1, 2021False Negative Result; False Negative Result

  (B)(6) ADVIA CENTAUR XPT (B)(6) RESULTS WERE OBTAINED ON A PATIENT SAMPLE AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THE (B)(6) RESULT WAS CONSIDERED DISCORDANT COMPARED TO AN (B)(6) VIRAL LOAD RESULT OBTAINED ON AN ALTERNATE (B)(6) TEST METHOD (#1). A NEW SAMPLE WAS COLLECTED AND TESTED ON THE SAME ADVIA CENTAUR XPT INSTRUMENT, RESULTING (B)(6). THE PATIENT SAMPLE WAS RUN ON AN ALTERNATE (B)(6) TEST METHOD (#2), RESULTING (B)(6). THE (B)(6) VIRAL LOAD RESULT WAS CONSIDERED TO BE THE CORRECT RESULT REPORTED TO THE PHYSICIAN(S). 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 12406126 ↗
• MalfunctionMay 14, 2021False Negative Result; False Negative Result

  THE CUSTOMER REPORTED AN ADVIA CENTAUR XPT (B)(6) SURFACE ANTIGEN II ((B)(6)) RESULT FOR A PATIENT SAMPLE THAT WAS (B)(6) ON TWO ALTERNATE METHODS. THE (B)(6) RESULT DID NOT AGREE WITH THE CLINICAL PICTURE. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XPT (B)(6) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824563 ↗
• MalfunctionApr 10, 2020False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  A CUSTOMER OBTAINED FALSE NEGATIVE (NON-REACTIVE) RESULTS FOR ONE PATIENT WITH ADVIA CENTAUR XP (B)(6) ON 2 TESTING DATES ((B)(6) 2020, (B)(6) 2020) COMPARED TO A PREVIOUS POSITIVE (REACTIVE) RESULT. THE CUSTOMER INDICATES THAT THE PATIENT IS CONSIDERED POSITIVE FOR (B)(6). THE FALSE NEGATIVE RESULTS FROM (B)(6) 2020 WERE NOT REPORTED TO PHYSICIAN. THE FALSE NEGATIVE RESULT FROM (B)(6) 2020 WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED FOR THIS TESTING DATE. 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 9950991 ↗
• MalfunctionApr 10, 2020False Negative Result; No Apparent Adverse Event; False Negative Result; No Apparent Adverse Event

  A CUSTOMER OBTAINED FALSE NEGATIVE (NON-REACTIVE) RESULTS FOR ONE PATIENT WITH ADVIA CENTAUR XP (B)(6) ON 2 TESTING DATES ((B)(6) 2020, (B)(6) 2020) COMPARED TO A PREVIOUS POSITIVE (REACTIVE) RESULT. THE CUSTOMER INDICATES THAT THE PATIENT IS CONSIDERED POSITIVE FOR (B)(6). THE FALSE NEGATIVE RESULTS FROM (B)(6) 2020 WERE NOT REPORTED TO PHYSICIAN. THE FALSE NEGATIVE RESULT FROM (B)(6) 2020 WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED FOR THIS TESTING DATE. 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 9950990 ↗
• MalfunctionApr 9, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FALSE NEGATIVE ADVIA CENTAUR XP HBSAGII (HBSII) RESULTS WERE OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT COMPARED TO A POSITIVE HBSAG RESULT INITIALLY OBTAINED AT AN ALTERNATE SISTER HOSPITAL (HOLY CROSS) UTILIZING AN ALTERNATE HBSAG TEST METHOD. THE SAME SAMPLE HAD BEEN SENT TO THE CUSTOMER FOR HBSAG CONFIRMATION TESTING BY THE SISTER HOSPITAL. THE POSITIVE ALTERNATE HBSAG RESULT WAS CONFIRMED BY THE CUSTOMER WHEN TESTED WITH ADVIA CENTAUR HBSAG CONFIRMATORY. THE POSITIVE HBSAG RESULT FROM THE SISTER HOSPITAL 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 HBSII RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9946160 ↗
• MalfunctionNov 18, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE WITH THE ADVIA CENTAUR XP HBSAGII (HBSII) ASSAY. INITIAL RESULT WAS REPORTED TO PHYSICIAN, WHO QUESTIONED THE RESULT BECAUSE THIS PATIENT HAS HISTORICALLY BEEN HBSII (B)(6) SINCE 2010. THE SAME SAMPLE WAS RETESTED ON A DIFFERENT ADVIA CENTAUR XP INSTRUMENT AND A (B)(6) RESULT WAS AGAIN OBTAINED. QUALITY CONTROL AND CALIBRATION WERE CHECKED AND WERE WITHIN LABORATORY ACCEPTABLE RANGE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED DUE TO THE (B)(6) HBSII RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) HBSII RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9334478 ↗
• MalfunctionNov 18, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE WITH THE ADVIA CENTAUR XP HBSAGII (HBSII) ASSAY. INITIAL RESULT WAS REPORTED TO PHYSICIAN, WHO QUESTIONED THE RESULT BECAUSE THIS PATIENT HAS HISTORICALLY BEEN HBSII (B)(6) SINCE 2010. THE SAME SAMPLE WAS RETESTED ON A DIFFERENT ADVIA CENTAUR XP INSTRUMENT AND A (B)(6) RESULT WAS AGAIN OBTAINED. QUALITY CONTROL AND CALIBRATION WERE CHECKED AND WERE WITHIN LABORATORY ACCEPTABLE RANGE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED DUE TO THE (B)(6) HBSII RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) HBSII RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9334476 ↗
• MalfunctionFeb 12, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT (B)(6) ADVIA CENTAUR XPT (B)(6) RESULT WAS OBTAINED FOR A PATIENT SAMPLE WITH LOT 142. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT PRESENTS CLINICAL SIGNS OF (B)(6). THE PATIENT SAMPLE WAS TESTED AT ANOTHER SITE AND THE RESULT WAS (B)(6). THE FIRST SAMPLE FROM THE PATIENT WAS REPEATED ON ALTERNATE METHOD 1 AND THE RESULT WAS (B)(6). THE SECOND SAMPLE WAS REPEATED ON ALTERNATE METHOD 2 AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED WITH THE ADVIA CENTAUR XPT (B)(6) LOT 144 AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS REPEATED WITH THE ADVIA CENTAUR XPT (B)(6) LOT 142 AND THE RESULT WAS (B)(6). PATIENT TREATMENT AND INTERVENTION WERE DELAYED. THE CUSTOMER STATED HOSPITALIZATION OF THE PATIENT AND RETROVIRAL MEDICATION SUPPLY. CURRENTLY THE PATIENT IS HOSPITALIZED FOR TREATMENT OF (B)(6). THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8333027 ↗
• MalfunctionFeb 12, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT (B)(6) ADVIA CENTAUR XPT HBSAGII (HBSII) RESULT WAS OBTAINED FOR A PATIENT SAMPLE WITH LOT 142. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT PRESENTS CLINICAL SIGNS OF (B)(6). THE PATIENT SAMPLE WAS TESTED AT ANOTHER SITE AND THE RESULT WAS (B)(6). THE FIRST SAMPLE FROM THE PATIENT WAS REPEATED ON ALTERNATE METHOD 1 AND THE RESULT WAS (B)(6). THE SECOND SAMPLE WAS REPEATED ON ALTERNATE METHOD 2 AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED WITH THE ADVIA CENTAUR XPT HBSAGII (HBSII) LOT 144 AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS REPEATED WITH THE ADVIA CENTAUR XPT HBSAGII (HBSII) LOT 142 AND THE RESULT WAS (B)(6). PATIENT TREATMENT AND INTERVENTION WERE DELAYED. THE CUSTOMER STATED HOSPITALIZATION OF THE PATIENT AND RETROVIRAL MEDICATION SUPPLY. CURRENTLY THE PATIENT IS HOSPITALIZED FOR TREATMENT OF (B)(6). THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HBSAGII RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331945 ↗
• MalfunctionFeb 12, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT (B)(6) ADVIA CENTAUR XPT HBSAGII (HBSII) RESULT WAS OBTAINED FOR A PATIENT SAMPLE WITH LOT 142. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT PRESENTS CLINICAL SIGNS OF (B)(6). THE PATIENT SAMPLE WAS TESTED AT ANOTHER SITE AND THE RESULT WAS (B)(6). THE FIRST SAMPLE FROM THE PATIENT WAS REPEATED ON ALTERNATE METHOD 1 AND THE RESULT WAS (B)(6). THE SECOND SAMPLE WAS REPEATED ON ALTERNATE METHOD 2 AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED WITH THE ADVIA CENTAUR XPT HBSAGII (HBSII) LOT 144 AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS REPEATED WITH THE ADVIA CENTAUR XPT HBSAGII (HBSII) LOT 142 AND THE RESULT WAS (B)(6). PATIENT TREATMENT AND INTERVENTION WERE DELAYED. THE CUSTOMER STATED HOSPITALIZATION OF THE PATIENT AND RETROVIRAL MEDICATION SUPPLY. CURRENTLY THE PATIENT IS HOSPITALIZED FOR TREATMENT OF (B)(6). THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HBSAGII RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331944 ↗
• MalfunctionJun 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER OBSERVED INITIAL (B)(6) RESULTS THAT WERE (B)(6). (B)(6) RESULTS WERE NOT CONFIRMED. ADDITIONAL TESTING OF THE SAME SAMPLE AND A SUBSEQUENT SAMPLE FROM THE SAME PATIENT YIELDED (B)(6) RESULTS AND NOT CONFIRMED CONF RESULTS. A PREVIOUS (B)(6) RESULT WAS (B)(6). THE CUSTOMER STATED THAT A RESULT OF (B)(6) WAS REPORTED TO THE PHYSICIAN. THE PATIENT IS A DIALYSIS PATIENT. BASED ON THE (B)(6) RESULTS, THE PATIENT WAS PLACED ON A DIALYSIS MACHINE THAT IS USED FOR PATIENT WITH (B)(6) RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULTS. THE PATIENT IS NOW DECEASED DUE POSSIBLE KIDNEY FAILURE. MDR 1219913-2018-00174 IS BEING FILED FOR SAMPLE TEST RESULTS GENERATED ON MAY 15, 2018 FOR THE SAME PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601615 ↗
• MalfunctionJun 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER OBSERVED INITIAL ADVIA CENTAUR XPT HBSAGII RESULTS THAT WERE (B)(6). ADVIA CENTAUR XPT HBSAGII CONFIRMATORY (CONF) RESULTS WERE NOT CONFIRMED. ADDITIONAL TESTING OF THE SAME SAMPLE AND A SUBSEQUENT SAMPLE FROM THE SAME PATIENT YIELDED (B)(6) ADVIA CENTAUR XPT HBSAGII RESULTS AND NOT CONFIRMED CONF RESULTS. A PREVIOUS ADVIA CENTAUR HBSAGII RESULT WAS (B)(6). THE CUSTOMER STATED THAT A RESULT OF (B)(6) WAS REPORTED TO THE PHYSICIAN. THE PATIENT IS A DIALYSIS PATIENT. BASED ON THE (B)(6) ADVIA CENTAUR XPT HBSAGII RESULTS, THE PATIENT WAS PLACED ON A DIALYSIS MACHINE THAT IS USED FOR PATIENT WITH (B)(6) RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XPT HBSAGII RESULTS. THE PATIENT IS NOW DECEASED DUE TO POSSIBLE KIDNEY FAILURE. MDR 1219913-2018-00162 IS BEING FILED FOR SAMPLE TEST RESULTS GENERATED ON (B)(6) 2018 FOR THE SAME PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601609 ↗