ADVIA Centaur® HBcT 10309508Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414498096), received between Oct 29, 2019 and Feb 7, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (P040004); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2024False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED A NON-REACTIVE HBC TOTAL (HBCT) RESULT ON ONE PATIENT SAMPLE TESTED WITH LOT 188 ON AN ADVIA CENTAUR XPT INSTRUMENT, THAT WAS CONSIDERED DISCORDANT RELATIVE TO A REACTIVE RESULT ON A DIFFERENT SAMPLE FROM THE SAME PATIENT USING AN ALTERNATE TESTING METHOD. THE INITIAL ADVIA CENTAUR XPT HBCT NON-REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE PHYSICIAN BELIEVED THE REACTIVE RESULT ON THE ALTERNATE METHOD TO BE THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658542 ↗
• MalfunctionFeb 7, 2024False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED A NON-REACTIVE HBC TOTAL (HBCT) RESULT ON ONE PATIENT SAMPLE TESTED WITH LOT 188 ON AN ADVIA CENTAUR XPT INSTRUMENT, THAT WAS CONSIDERED DISCORDANT RELATIVE TO A REACTIVE RESULT ON A DIFFERENT SAMPLE FROM THE SAME PATIENT USING AN ALTERNATE TESTING METHOD. THE INITIAL ADVIA CENTAUR XPT HBCT NON-REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE PHYSICIAN BELIEVED THE REACTIVE RESULT ON THE ALTERNATE METHOD TO BE THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658532 ↗
• MalfunctionNov 16, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED OBSERVATION OF ANTI-HEPATITIS B CORE TOTAL (HBCT) NON-REACTIVE (NEGATIVE) RESULTS ON THREE DIFFERENT PATIENT(S) SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT. THE SAMPLES WERE REPEATED ON THE SAME ADVIA CENTAUR XP INSTRUMENT, AND THE RESULTS WERE NON-REACTIVE (NEGATIVE). THE ORIGINAL HBCT RESULTS WERE REPORTED TO THE PHYSICIAN(S). UPON REPEAT TESTING THE SAMPLES WITH ANTI-HEPATITIS B CORE TOTAL 2 (HBCT2) ASSAY ON THE SAME ADVIA CENTAUR XP INSTRUMENT, THE RESULTS OBTAINED WERE REACTIVE (POSITIVE). THESE RESULTS WERE GENERATED AS PART OF A METHOD COMPARISON BEFORE IMPLEMENTATION OF THE ASSAY AND THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN WHICH RESULTS ARE CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NON-REACTIVE (NEGATIVE) HBCT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18151919 ↗
• InjuryOct 29, 2019False Negative Result; False Negative Result

  A CUSTOMER ALLEGED THAT A (B)(6) ADVIA CENTAUR XP HEPATITIS B CORE TOTAL (ANTI-HBCT) RESULT WAS OBTAINED ON (B)(6) 2016 FOR A PATIENT (NON-CADAVERIC SAMPLE) WHO WAS A LIVER TRANSPLANT DONOR. THE COMPLAINT INDICATES THAT A LIVER FROM THIS DONOR WAS TRANSPLANTED TO A RECIPIENT WHO SUBSEQUENTLY DEVELOPED ACUTE (B)(6) INFECTION. THE DONOR SAMPLE WAS THEN RETESTED ON AN ALTERNATE METHOD ON (B)(6) 2019 AND A SECOND ALTERNATE METHOD ON (B)(6) 2019 AND WEAK (B)(6) RESULTS WERE OBTAINED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER, INCLUDING DONOR AND RECIPIENT CLINICAL HISTORY. THE INFORMATION ATTRIBUTED TO THIS EVENT IS DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAS NOT BEEN VERIFIED.

  Patient problems: Hepatitis

  MAUDE report 9253138 ↗
• InjuryOct 29, 2019False Negative Result; False Negative Result

  A CUSTOMER ALLEGED THAT A (B)(6) ADVIA CENTAUR XP HEPATITIS B CORE TOTAL (ANTI-HBCT) RESULT WAS OBTAINED ON (B)(6) FOR A PATIENT (NON-CADAVERIC SAMPLE) WHO WAS A LIVER TRANSPLANT DONOR. THE COMPLAINT INDICATES THAT A LIVER FROM THIS DONOR WAS TRANSPLANTED TO A RECIPIENT WHO SUBSEQUENTLY DEVELOPED ACUTE HBV INFECTION. THE DONOR SAMPLE WAS THEN RETESTED ON AN ALTERNATE METHOD ON (B)(6) 2019 AND A SECOND ALTERNATE METHOD ON (B)(6) 2019 AND WEAK POSITIVE RESULTS WERE OBTAINED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER, INCLUDING DONOR AND RECIPIENT CLINICAL HISTORY. THE INFORMATION ATTRIBUTED TO THIS EVENT IS DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAS NOT BEEN VERIFIED.

  Patient problems: Hepatitis

  MAUDE report 9253137 ↗
• InjuryOct 29, 2019False Negative Result; False Negative Result

  SIEMENS WAS INFORMED THAT A PATIENT WHO HAD PREVIOUSLY BEEN (B)(6) FOR (B)(6) DEVELOPED (B)(6) DURING TRANSPLANT RELATED IMMUNOSUPPRESSION AFTER AN AUTOLOGOUS BONE MARROW TRANSPLANT (PATIENT IS DONOR AND RECIPIENT). SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER, INCLUDING DETAILED CLINICAL HISTORY OF THE PATIENT. THE INFORMATION ATTRIBUTED TO THIS EVENT IS DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAS NOT BEEN VERIFIED.

  Patient problems: Hepatitis

  MAUDE report 9253132 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040004. One submission often covers many models, so check the product and lot details in each record.

• Z-0102-2015 · Sep 15, 2014 · Terminated
  Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay
• Z-0103-2015 · Sep 15, 2014 · Terminated
  ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitr