ADVIA Centaur HCVRecalls & reported problems across all models

We found 2 models of ADVIA Centaur HCV by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 111 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Jul 28, 2025 — classified as 111 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (17 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 HCV problems

ADVIA Centaur HCV models

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

• ADVIA Centaur® HCV 10309061

  Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus
  108 reports
• ADVIA Centaur HCV 11203483

  ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
  3 reports

Recent ADVIA Centaur HCV adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED AN OBSERVATION OF NON-REACTIVE (NEGATIVE) ADVIA CENTAUR ANTIBODIES TO HEPATITIS C VIRUS (AHCV) RESULTS OBTAINED ON A PATIENT SAMPLE, WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE METHOD. THE INITIAL NON-REACTIVE (NEGATIVE) RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED ON (B)(6) 2025 USING AN ALTERNATE METHOD AND OBTAINED A SIMILAR NON-REACTIVE (NEGATIVE) RESULT, WHICH WAS CONSIDERED DISCORDANT. ON THE FOLLOWING DAY, THE SAMPLE WAS AGAIN RETESTED ON AN ADVIA CENTAUR XP SYSTEM AND OBTAINED A SIMILAR NON-REACTIVE (NEGATIVE) RESULT, WHICH WAS CONSIDERED DISCORDANT. SUBSEQUENTLY, THE SAMPLE WAS RETESTED USING ANOTHER ALTERNATE METHOD AND OBTAINED A REACTIVE (POSITIVE) RESULT, WHICH WAS CONSIDERED CORRECT. DUE TO INSUFFICIENT SAMPLE VOLUME, THE CUSTOMER DID NOT PERFORM FURTHER TESTING, INCLUDING A MOLECULAR BIOLOGY TEST. NO AHCV RESULTS WERE REPORTED TO THE PHYSICIAN(S) FOR THIS PATIENT. THE LABORATORY HAS REQUESTED COLLECTION OF A NEW SAMPLE, DEPENDING UPON THE PATIENT'S RETURN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT(S) DISC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636702 ↗
• MalfunctionJul 28, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED AN OBSERVATION OF NON-REACTIVE (NEGATIVE) ADVIA CENTAUR ANTIBODIES TO HEPATITIS C VIRUS (AHCV) RESULTS OBTAINED ON A PATIENT SAMPLE, WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE METHOD. THE INITIAL NON-REACTIVE (NEGATIVE) RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RETESTED ON (B)(6) 2025 USING AN ALTERNATE METHOD AND OBTAINED A SIMILAR NON-REACTIVE (NEGATIVE) RESULT, WHICH WAS CONSIDERED DISCORDANT. ON THE FOLLOWING DAY, THE SAMPLE WAS AGAIN RETESTED ON AN ADVIA CENTAUR XP SYSTEM AND OBTAINED A SIMILAR NON-REACTIVE (NEGATIVE) RESULT, WHICH WAS CONSIDERED DISCORDANT. SUBSEQUENTLY, THE SAMPLE WAS RETESTED USING ANOTHER ALTERNATE METHOD AND OBTAINED A REACTIVE (POSITIVE) RESULT, WHICH WAS CONSIDERED CORRECT. DUE TO INSUFFICIENT SAMPLE VOLUME, THE CUSTOMER DID NOT PERFORM FURTHER TESTING, INCLUDING A MOLECULAR BIOLOGY TEST. NO AHCV RESULTS WERE REPORTED TO THE PHYSICIAN(S) FOR THIS PATIENT. THE LABORATORY HAS REQUESTED COLLECTION OF A NEW SAMPLE, DEPENDING UPON THE PATIENT'S RETURN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT IN ASSOCIATION WITH THE OBSERVED RESULT(S) DISC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629035 ↗
• MalfunctionApr 23, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTS A DISCORDANT NON-REACTIVE (NEGATIVE) ADVIA CENTAUR XPT HCV (AHCV) RESULT FOR A FEMALE RENAL PATIENT (SAMPLE (B)(6) ON (B)(6) 2025) WHO RESULTED AS POSITIVE AT ANOTHER LAB THE NEXT DAY USING AN ALTERNATE TEST METHOD. THE DISCORDANCE WAS IDENTIFIED DURING PREPARATION FOR A LIVE DONOR RENAL TRANSPLANT. THE PATIENT WAS TESTED AT THE CUSTOMER SITE AND RESULTED NEGATIVE. THIS WAS NOT QUESTIONED AT THE TIME BECAUSE THE PATIENT HAD HISTORICALLY RESULTED NEGATIVE WHEN TESTED AT THE CUSTOMER SITE AS PART OF DIALYSIS MANAGEMENT. THE NEGATIVE RESULT WAS QUESTIONED WHEN THE PATIENT WAS TESTED AT ANOTHER LAB THE NEXT DAY USING AN ALTERNATE TEST METHOD AND RESULTED POSITIVE. THE NEPHROLOGY TEAM AT THE CUSTOMER SITE WAS NOTIFIED OF THE DISCORDANCE, WHICH PROMPTED THEIR INVESTIGATION. THE TEAM CONCLUDED THAT PATIENTS HAD A PAST BUT CLEARED HCV INFECTION AND THE TRANSPLANT OCCURRED ON (B)(6) 2025 AS PLANNED WITH NO DELAY. THERE ARE NO REPORTS OF ALTERED TREATMENT, DELAYS OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895432 ↗
• MalfunctionJan 3, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ADVIA CENTAUR HCV (AHCV) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AHCV REAGENT LOT#: 473 WAS IN USE AT THE TIME. AN INITIAL REACTIVE (POSITIVE) RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE SAME SAMPLE WAS RETESTED ON THE SAME ANALYZER AND OBTAINED A NONREACTIVE (NEGATIVE) RESULT. BOTH RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE NONREACTIVE (NEGATIVE) RESULT WAS CONSIDERED DISCORDANT BY THE CUSTOMER. THEREFORE, A FOLLOW-UP TESTING WAS PERFORMED FOR THE SAME SAMPLE IN DUPLICATE WHICH PRODUCED REACTIVE (POSITIVE) RESULTS. THE REACTIVE (POSITIVE) RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065826 ↗
• MalfunctionOct 25, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTS AN OBSERVATION OF A NON-REACTIVE (NEGATIVE) ADVIA CENTAUR HCV (AHCV) RESULT WHICH WAS CONSIDERED DISCORDANT RELATIVE TO CLINICAL EXPECTATION. AHCV REAGENT LOT# 466 WAS IN USE AT THE TIME. AN INITIAL REACTIVE (POSITIVE) RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE INITIAL REACTIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). PER ADVIA CENTAUR HCV (AHCV) INSTRUCTIONS FOR USE (IFU), THE CUSTOMER PERFORMED A FOLLOW-UP TESTING WITH THE SAME SAMPLE, WHICH PRODUCED A NONREACTIVE (NEGATIVE) RESULT. THIS RESULT WAS CONSIDERED DISCORDANT BY THE CUSTOMER. THE SAME SAMPLE WAS THEN REPEATED IN DUPLICATE WHICH PRODUCED REACTIVE (POSITIVE) RESULTS SIMILAR TO THE INITIAL RESULT. THE REACTIVE RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S) AS IT MATCHED THE CLINICAL EXPECTATION FOR THE AFFECTED PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531637 ↗
• MalfunctionApr 4, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF NONREACTIVE ADVIA CENTAUR HCV (AHCV) RESULTS WHICH WERE DISCORDANT RELATIVE TO PATIENT HISTORY AND ALTERNATE-METHOD TESTING. AHCV REAGENT LOT 459 WAS IN USE AT THE TIME. TWO PATIENTS PRODUCED NONREACTIVE (NEGATIVE) RESULTS IN INITIAL TESTING. THE PHYSICIAN QUESTIONED THESE RESULTS BASED ON PATIENT HISTORY. THE SAMPLES WERE RE-TESTED IN DUPLICATE THE FOLLOWING DAY, AND BOTH PRODUCED REACTIVE (POSITIVE) RESULTS WHICH WERE ACCEPTED AS CORRECT. CORRECTIVE REPORTS WERE FILED FOR BOTH PATIENTS; THE PHYSICIAN STATES THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040282 ↗
• MalfunctionNov 14, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE ADVIA CENTAUR HCV (AHCV) RESULT WHICH WAS DISCORDANT RELATIVE TO PATIENT HISTORY AND ALTERNATE-METHOD TESTING. AHCV REAGENT LOT 445 WAS IN USE AT THE TIME. A NONREACTIVE (NEGATIVE) AHCV RESULT WAS OBTAINED FOR A PATIENT WITH A HISTORY OF POSITIVE HCV RESULTS SINCE 2018. THIS NEGATIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN, AND AN ADDITIONAL TEST WAS PERFORMED USING AN ALTERNATE METHOD. THE ALTERNATE METHOD PRODUCED A POSITIVE RESULT, WHICH WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18134238 ↗
• MalfunctionAug 24, 2023False Negative Result; False Negative Result

  A NONREACTIVE (NEGATIVE) HCV (AHCV) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR CP SYSTEM WHICH WAS CONSIDERED DISCORDANT WITH THE POSITIVE RESULTS FROM TWO ALTERNATE METHODS. THE DISCORDANT NONREACTIVE (NEGATIVE) RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE POSITIVE RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NONREACTIVE (NEGATIVE) AHCV RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611131 ↗
• MalfunctionAug 3, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NEGATIVE ADVIA CENTAUR XPT HCV (AHCV) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. AN INITIAL NONREACTIVE (HCV-NEGATIVE) AHCV RESULT WAS OBTAINED. REPEAT TESTING BY AN ALTERNATE METHOD PRODUCED A POSITIVE RESULT. WHEN THE SAMPLE WAS TESTED AT AN EXTERNAL REFERENCE LABORATORY, AN INDETERMINATE RESULT WAS OBTAINED. THE INDETERMINATE RESULT WAS ULTIMATELY REPORTED FOR THE PATIENT. IT IS NOTED THAT THE SAMPLE WAS NEGATIVE BY HCV RNA (PCR) TESTING. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED NOR OF ANY ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AHCV RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160426 ↗
• MalfunctionAug 2, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NEGATIVE ADVIA CENTAUR XPT HCV (AHCV) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. AN INITIAL NONREACTIVE (HCV-NEGATIVE) AHCV RESULT WAS OBTAINED. REPEAT TESTING BY AN ALTERNATE METHOD PRODUCED A POSITIVE RESULT. WHEN THE SAMPLE WAS TESTED AT AN EXTERNAL REFERENCE LABORATORY, ANOTHER POSITIVE RESULT WAS OBTAINED. FOLLOWING THE POSITIVE DETECTION OF HCV RNA, THE SAMPLE WAS GENOTYPE-TESTED, WITH A RESULT OF GENOTYPE 1B, WHERE GENTOTYPE 6 (SUBTYPES C-L) CANNOT BE EXCLUDED. THE HCV-POSITIVE RESULT WAS ACCEPTED AS CORRECT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED NOR OF ANY ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AHCV RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15148304 ↗
• MalfunctionAug 1, 2022False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NEGATIVE ADVIA CENTAUR XPT HCV (AHCV) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. AN INITIAL NONREACTIVE (HCV-NEGATIVE) AHCV RESULT WAS OBTAINED. REPEAT TESTING BY AN ALTERNATE METHOD PRODUCED A POSITIVE RESULT. WHEN THE SAMPLE WAS TESTED AT AN EXTERNAL REFERENCE LABORATORY, AN INDETERMINATE RESULT WAS OBTAINED. THE INDETERMINATE RESULT WAS ULTIMATELY REPORTED FOR THE PATIENT. IT IS NOTED THAT THE SAMPLE WAS NEGATIVE BY HCV RNA (PCR) TESTING. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED NOR OF ANY ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AHCV RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15142693 ↗
• MalfunctionNov 4, 2021False Negative Result; False Negative Result

  THIS MDR IF BEING FILED BASED ON A REVIEW OF THE FOLLOWING PUBLICATION: ADVANCES IN LABORATORY MEDICINE 2021; 2(2): 297-300: "FALSE-SERONEGATIVE HCV INFECTION MOTIVATED BY INTERFERENCE WITH CRYOGLOBULINS" AUTHORS: GEMMA RECIO COMÍ, CARMEN MOLINA CLAVERO, SANDRA CALABUIG BALLESTER, CLARA BENAVENT BOFILL, ESTER PICÓ-PLANA, CARLA MARTÍN GRAU, CRISTINA GUTIÉRREZ FORNÉS, MA TERESA SANS MATEU THIS CASE REPORT DESCRIBES A FALSE-NEGATIVE HCV DETERMINATION OBSERVED WHEN USING THE ADVIA CENTAUR XPT HCV (AHCV) ASSAY. THE CASE INVOLVES AN (B)(6) WOMAN WHO WAS PRESENTED TO THE NEPHROLOGY DEPARTMENT WITH ACUTE RENAL FAILURE AND PULMONARY EDEMA THAT REQUIRED URGENT HAEMODIALYSIS. THE PATIENT EXHIBITED DROWSINESS AND DISORIENTATION, BUT ACUTE PATHOLOGY OR INFECTIOUS DISEASE WERE EXCLUDED BY A CRANIAL COMPUTED TOMOGRAPHY (CT) AND A LUMBAR PUNCTURE. THE PATIENT SHOWED MELTZER'S TRIAD, COMPOSED OF PURPURIC LESIONS, ARTHRALGIAS AND WEAKNESS. INITIAL LABORATORY TESTS CONFIRMED KIDNEY INJURY. PROTEINURIA WAS NOTED, AND HAEMATURIA WITH DYSMORPHIC ERYTHROCYTES WAS VISUALIZED IN URINARY SEDIMENT. TESTING REVEALED NORMOCHROMIC AND NORMOCYTIC ANAEMIA, AND INCREASED LEUKOCYTE COUNT WITH NEUTROPHILIA. NO ABNOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751606 ↗
• MalfunctionDec 4, 2020False Negative Result; False Negative Result

  (B)(6) ADVIA CENTAUR XP (B)(6) RESULTS WERE OBTAINED FROM THE SAME PATIENT AND REPORTED TO THE PHYSICIAN(S). THE (B)(6) RESULTS ARE CONSIDERED DISCORDANT COMPARED TO A (B)(6) ALTERNATE (B)(6)TEST METHOD. THE CUSTOMER PERFORMED (B)(6) REPEAT TESTING OF THE SAME SAMPLE ON AN ADVIA CENTAUR XPT, RESULTING (B)(6). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT(S), (B)(6) ADVIA CENTAUR XP (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10946363 ↗
• MalfunctionDec 4, 2020False Negative Result; False Negative Result

  FALSE NONREACTIVE ADVIA CENTAUR XP HEPATITIS C (AHCV) RESULTS WERE OBTAINED FROM THE SAME PATIENT AND REPORTED TO THE PHYSICIAN(S). THE NONREACTIVE AHCV RESULTS ARE CONSIDERED DISCORDANT COMPARED TO A REACTIVE ALTERNATE HCV TEST METHOD. THE CUSTOMER PERFORMED AHCV REPEAT TESTING OF THE SAME SAMPLE ON AN ADVIA CENTAUR XPT, RESULTING NONREACTIVE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT(S), FALSELY NONREACTIVE ADVIA CENTAUR XP HEPATITIS C (AHCV) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10946362 ↗
• MalfunctionDec 4, 2020False Negative Result; False Negative Result

  (B)(6) ADVIA CENTAUR XPT HEPATITIS C (AHCV) RESULTS WERE OBTAINED FROM THE SAME PATIENT AND REPORTED TO THE PHYSICIAN(S). THE (B)(6) RESULTS ARE CONSIDERED DISCORDANT COMPARED TO A (B)(6) ALTERNATE (B)(6) TEST METHOD. THE CUSTOMER PERFORMED INITIAL (B)(6) TESTING OF THE SAME SAMPLE ON AN ADVIA CENTAUR XP, RESULTING (B)(6). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT(S), (B)(6) ADVIA CENTAUR XPT HEPATITIS C (AHCV) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10946319 ↗

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