ADVIA Centaur® HCV 10309061Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00630414473161), received between Jun 29, 2017 and Jul 28, 2025 — classified as 108 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (14 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 25 most recent of 108 reports, 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 ↗
• 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 ↗
• MalfunctionNov 4, 2020False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED NON-REACTIVE (NEGATIVE) ADVIA CENTAUR XPT (B)(6) ASSAY RESULTS FOR TWO SAMPLES FROM ONE PATIENT WHICH ARE CONSIDERED DISCORDANT RELATIVE TO A POSITIVE VIRAL LOAD RESULT FOR THE SAME PATIENT. THE NON-REACTIVE RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED NOR OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY NON-REACTIVE (B)(6) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10784150 ↗
• MalfunctionJun 3, 2020False Negative Result; False Negative Result

  A FALSE NEGATIVE RESULT WAS OBTAINED USING ADVIA CENTAUR XPT HCV (AHCV) IMMUNOASSAY. AN INITIAL POSITIVE RESULT WAS OBTAINED USING ADVIA CENTAUR XPT HCV (AHCV) . THE CUSTOMER RERAN THE SAMPLE PER THEIR LABORATORY POLICY ON THE SAME INSTRUMENT ON THE SAME DAY WITH THE SAME SAMPLE. THE INSTRUMENT TESTED THE SAMPLE IN DUPLICATE, WHICH RESULTED IN A POSITIVE AND A NEGATIVE RESULT. BOTH RERUN RESULTS WERE UPLOADED TO THE LIS. THE RESULT PROVIDED TO PHYSICIAN WAS "NON-REACTIVE". THE CUSTOMER FILLED OUT A CORRECTED REPORT INCLUDING THE POSITIVE AND NEGATIVE RESULTS AND SUBMITTED IT TO PHYSICIAN. THE CUSTOMER BELIEVES THE POSITIVE RESULT TO BE CORRECT. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCV RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10115591 ↗
• MalfunctionFeb 11, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) ADVIA CENTAUR XP HCV (AHCV) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. ON (B)(6), THE HCV-RNA TESTING WAS PERFORMED AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED AGAIN ON THE SAME ADVIA CENTAUR XP SYSTEM AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD ON THE SAME DAY AT A DIFFERENT LOCATION. THE RESULTS WERE (B)(6). ON (B)(6), THE PATIENT SAMPLE WAS TESTED AT ANOTHER LABORATORY AND THE RESULT WAS (B)(6) ON THE ALTERNATE METHOD. ON (B)(6), THE PATIENT SAMPLE WAS TESTED AT ANOTHER LABORATORY ON THE ADVIA CENTAUR XP. THE HCV RESULT WAS (B)(6). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN. IT IS UNKNOWN IF THE RESULTS WERE QUESTIONED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HCV RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9695515 ↗
• MalfunctionFeb 11, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) ADVIA CENTAUR XP HCV (AHCV) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. ON (B)(6) THE SAMPLE ARRIVED AT THE LABORATORY FOR IMMUNOASSAY AND MOLECULAR HCV TESTING. THE HCV-RNA TESTING RESULTED (B)(6). ON (B)(6), THE SAMPLE FOR HCV TESTING RESULTED (B)(6) ON THE ADVIA CENTAUR XP WITH LOT 339. ON (B)(6), THE PATIENT SAMPLE WAS TESTED AT ANOTHER LABORATORY ON THE ADVIA CENTAUR XP WITH LOT 335 AND THE HCV RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AT A DIFFERENT LOCATION AND THE RESULT WAS (B)(6). PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HCV RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9695514 ↗
• MalfunctionFeb 11, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) ADVIA CENTAUR XP (B)(6) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. ON JANUARY 15TH THE SAMPLE ARRIVED AT THE LABORATORY FOR IMMUNOASSAY AND MOLECULAR (B)(6) TESTING. THE (B)(6)-RNA TESTING RESULTED (B)(6). ON JANUARY 23RD, THE SAMPLE FOR (B)(6) TESTING RESULTED (B)(6) ON THE ADVIA CENTAUR XP WITH LOT 339. ON JANUARY 24TH, THE PATIENT SAMPLE WAS TESTED AT ANOTHER LABORATORY ON THE ADVIA CENTAUR XP WITH LOT 335 AND THE (B)(6) RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AT A DIFFERENT LOCATION AND THE RESULT WAS (B)(6). PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XP (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9695504 ↗
• MalfunctionFeb 11, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) ADVIA CENTAUR XP HCV (AHCV) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. ON JANUARY 22ND, THE HCV-RNA TESTING WAS PERFORMED AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED AGAIN ON THE SAME ADVIA CENTAUR XP SYSTEM AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD ON THE SAME DAY AT A DIFFERENT LOCATION. THE RESULTS WERE (B)(6). ON JANUARY 23RD, THE PATIENT SAMPLE WAS TESTED AT ANOTHER LABORATORY AND THE RESULT WAS (B)(6) ON THE ALTERNATE METHOD. ON JANUARY 24TH, THE PATIENT SAMPLE WAS TESTED AT ANOTHER LABORATORY ON THE ADVIA CENTAUR XP. THE HCV RESULT WAS (B)(6). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN. IT IS UNKNOWN IF THE RESULTS WERE QUESTIONED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HCV RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9695492 ↗
• MalfunctionFeb 11, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) ADVIA CENTAUR XP HCV (AHCV) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. ON (B)(6) THE HCV-RNA TESTING WAS PERFORMED AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED AGAIN ON THE SAME ADVIA CENTAUR XP SYSTEM AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD ON THE SAME DAY AT A DIFFERENT LOCATION. THE RESULTS WERE (B)(6). ON (B)(6), THE PATIENT SAMPLE WAS TESTED AT ANOTHER LABORATORY AND THE RESULT WAS (B)(6) ON THE ALTERNATE METHOD. ON (B)(6), THE PATIENT SAMPLE WAS TESTED AT ANOTHER LABORATORY ON THE ADVIA CENTAUR XP. THE HCV RESULT WAS (B)(6). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN. IT IS UNKNOWN IF THE RESULTS WERE QUESTIONED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HCV RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9695488 ↗
• MalfunctionDec 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT LOW RESULT WAS OBTAINED FOR ONE PATIENT USING THE ADVIA CENTAUR XPT (B)(6) IMMUNOASSAY. AN INITIAL RESULT OF >11 INDEX (REACTIVE) WAS OBTAINED AND WAS RETESTED BECAUSE THE PATIENT WAS NEW TO THE LABORATORY AND BECAUSE THE INTERPRETATION OF RESULTS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES, "SAMPLES WITH A CALCULATED VALUE GREATER THAN OR EQUAL TO 1.00 INDEX VALUE ARE CONSIDERED REACTIVE FOR IGG ANTIBODIES TO HCV. IT IS RECOMMENDED THAT THE SAMPLE BE REPEATED IN DUPLICATE." A NON-REACTIVE RESULT WAS OBTAINED WITH THE RETEST. BOTH THE INITIAL AND RETEST RESULTS WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE NON-REACTIVE RESULT. DUE TO THE DISCORDANCE, A NEW SAMPLE WAS OBTAINED FROM THE SAME PATIENT. REACTIVE RESULTS WERE OBTAINED WITH THIS NEW SAMPLE, WHICH WAS REPORTED TO THE PHYSICIAN. ALL RESULTS WERE OBTAINED ON THE SAME DAY, ON THE SAME INSTRUMENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. 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 9526470 ↗
• MalfunctionOct 18, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) ADVIA CENTAUR XP HCV (AHCV) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN BECAUSE THE PREVIOUS (B)(6) RESULT WAS (B)(6). THE SAME PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE (B)(6). A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HCV RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9207584 ↗
• MalfunctionOct 18, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) ADVIA CENTAUR XP HCV (AHCV) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN BECAUSE THE PREVIOUS HCV RESULT WAS (B)(6). THE SAME PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE (B)(6). A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HCV RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9207583 ↗
• MalfunctionOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER STATED THAT TWO PATIENTS WERE RUN ON 2 SEPARATE OCCASIONS WITH (B)(6) RESULTS WITH THE ADVIA CENTAUR XP (B)(6) ASSAY. THIS CUSTOMER PERFORMS TESTING FOR PHARMACEUTICAL COMPANIES. COMPLAINT INFORMATION INDICATED THAT THE PATIENT HAS A HISTORY OF (B)(6) AND RESULTED (B)(6) AT A LOCAL LABORATORY, BUT RESULTS ARE NOT AVAILABLE. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9185198 ↗
• MalfunctionOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER STATED THAT TWO PATIENTS WERE RUN ON 2 SEPARATE OCCASIONS WITH (B)(6) RESULTS WITH THE ADVIA CENTAUR XP HCV (AHCV) ASSAY. THIS CUSTOMER PERFORMS TESTING FOR PHARMACEUTICAL COMPANIES. COMPLAINT INFORMATION INDICATED THAT THE PATIENT HAS A HISTORY OF (B)(6) AND RESULTED (B)(6) AT A LOCAL LABORATORY, BUT RESULTS ARE NOT AVAILABLE. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE (B)(6) HCV RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9185181 ↗
• MalfunctionOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER STATED THAT TWO PATIENTS WERE RUN ON 2 SEPARATE OCCASIONS WITH (B)(6) RESULTS WITH THE ADVIA CENTAUR XP (B)(6) ASSAY. THIS CUSTOMER PERFORMS TESTING FOR PHARMACEUTICAL COMPANIES. COMPLAINT INFORMATION INDICATED THAT THE PATIENT HAS A HISTORY OF (B)(6) AND RESULTED (B)(6) AT A LOCAL LABORATORY, BUT RESULTS ARE NOT AVAILABLE. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9185169 ↗