ADVIA Centaur® XP Analyzer 10364455Recalls & reported problems

Summary

The FDA's MAUDE database contains 243 adverse event reports that list this exact device (DI 00630414573564), received between Jun 29, 2017 and Apr 2, 2026 — classified as 243 malfunctions.

The most frequently reported specific device problem is “High Test Results” (48 reports).

8 other recalls cover devices cleared under the same FDA submission (K041133); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 243 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY ELEVATED PROGESTERONE (PRGE) RESULTS ON THREE PATIENT SAMPLES ON AN ADVIA CENTAUR XP ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CENTAUR XP ANALYZER. THE REPEAT RESULTS OBTAINED WERE CONSISTENT WITH THE PATIENT¿S CLINICAL HISTORY AND CONSIDERED CORRECT. THE REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED PRGE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24763832 ↗
• MalfunctionSep 15, 2025Leak/Splash; Smoking; Leak/Splash; Smoking

  THE CUSTOMER HEARD A LOUD NOISE AND OBSERVED SMOKE FROM AN ADVIA CENTAUR XP INSTRUMENT. THE CUSTOMER STATED THAT THEY IMMEDIATELY UNPLUGGED THE INSTRUMENT AND NOTICED A LEAK FROM THE REAGENT COMPARTMENT AND UNDERNEATH THE LEFT SIDE OF THE INSTRUMENT. THERE WERE NO INJURIES REPORTED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049352 ↗
• MalfunctionAug 28, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT TWO FALSELY ELEVATED ENHANCED ESTRADIOL (EE2) RESULTS, OBTAINED ON THE ADVIA CENTAUR XP INSTRUMENT, WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED AN ALTERNATE ADVIA CENTAUR XP INSTRUMENT AND THE SAME SAMPLES TO PERFORM REPEAT TESTING. THE REPEAT RESULTS WERE LOWER, CONSIDERED CORRECT, AND THE CUSTOMER ISSUED CORRECTED REPORTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916988 ↗
• MalfunctionAug 14, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ELEVATED ALPHA-FETOPROTEIN (AFP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CENTAUR XP ANALYZER. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO FALSELY ELEVATED AFP RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806895 ↗
• MalfunctionJul 22, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED PROGESTERONE (PRGE) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES WHEN PROCESSED ON AN ADVIA CENTAUR XP ANALYZER (S/N: (B)(6)). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) BUT WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ADVIA CENTAUR XP ANALYZER AND OBTAINED LOWER RESULTS. THE REPEAT RESULTS WERE CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT DUE TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566842 ↗
• MalfunctionJul 4, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED ALPHA FETOPROTEIN (AFP) AND CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES WHEN PROCESSED ON AN ADVIA CENTAUR XP ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE NOT QUESTIONED. THE SAMPLES WERE REPEATED ON THE ORIGINAL ANALYZER. THE REPEAT RESULTS OBTAINED WERE CONSISTENT WITH THE PATIENT'S HISTORY AND CONSIDERED CORRECT. THE REPEAT RESULTS WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED AFP AND CEA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22402253 ↗
• MalfunctionFeb 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ERRONEOUS CANCER ANTIGEN (BR 27.29) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA CENTAUR XP IMMUNOASSAY SYSTEM. FOR THE SAMPLE IDENTIFIED AS (B)(6), THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ORIGINAL INSTRUMENT. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS BR 27.29 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21396717 ↗
• MalfunctionDec 31, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUS CANCER ANTIGEN 27.29 (BR 27.29) RESULTS WERE OBTAINED ON 12 PATIENT SAMPLES ON AN ADVIA CENTAUR XP IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ORIGINAL SYSTEM. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE THE SPECIFIC PATIENT RESULTS DATA TO SIEMENS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS BR 27.29 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21046515 ↗
• MalfunctionDec 27, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON 12 PATIENT SAMPLES ON AN ADVIA CENTAUR XP ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CENTAUR ANALYZER. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER ALSO REPORTED A RESULT OF 31.6 MIU/ML WAS OBTAINED ON ANOTHER PATIENT SAMPLE, WHICH WAS REPORTED TO THE PHYSICIAN AND NOT CORRECTED, ALTHOUGH THE SAMPLE RECOVERED HIGHER WHEN THE CUSTOMER REPROCESSED THE SAMPLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027048 ↗
• MalfunctionDec 12, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT A FALSE REACTIVE HEPATITIS B SURFACE ANTIGEN HBSAGII (HBSII) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPEATED THE SAMPLE IN DUPLICATE AND OBTAINED REACTIVE RESULTS. THE CUSTOMER PERFORMED CONFIRMATORY TESTING USING THE HEPATITIS B SURFACE ANTIGEN (HBSAG) CONFIRMATORY (CONF) ASSAY AND THE SAMPLE WAS CONFIRMED TO BE REACTIVE. THE CUSTOMER INDICATED BASED ON THE HOSPITAL'S POLICY, SINCE THE PATIENT WAS CONFIRMED FOR BEING HBSAG REACTIVE AND WAS IN LABOR, THE PATIENT UNDERWENT A CAESAREAN SECTION. THEN, THE CUSTOMER RECALIBRATED THE ASSAY AND REPEATED THE SAMPLE ON THE SAME INSTRUMENT. THE REPEAT RESULTS WERE NON-REACTIVE. THE NON-REACTIVE REPEAT RESULT FOR HBSII WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917084 ↗
• MalfunctionNov 5, 2024Leak/Splash; Sparking; Leak/Splash; Sparking

  THE CUSTOMER REPORTED THAT THEY HEARD A BEEPING SOUND FROM A UNINTERRUPTIBLE POWER SUPPLY (UPS) THAT WAS CONNECTED TO AN IDLE ADVIA CENTAUR XP INSTRUMENT. SUBSEQUENTLY, THE CUSTOMER PRESSED THE POWER BUTTON ON THE UPS AND DETERMINED THAT SPARKS AND SMOKE EMITTED FROM THE ADVIA CENTAUR XP INSTRUMENT¿S POWER SUPPLY CORD. THE CUSTOMER DISCONNECTED THE SYSTEM FROM THE UPS AND OUTLET AND REMOVED ALL ONBOARD REAGENTS. PATIENT RESULTS WERE NOT IMPACTED OR DELAYED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR REQUIRED MEDICAL ATTENTION DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20606252 ↗
• MalfunctionOct 25, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT AN INITIAL REACTIVE ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN (AHBS2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE ADVIA CENTAUR XP ANALYZER. THE INITIAL REACTIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED IN DUPLICATES ON THE ORIGINAL INSTRUMENT AND RESULTS RECOVERED AS REACTIVE AND NON-REACTIVE RESPECTIVELY. THEN, THE CUSTOMER REPEATED THE SAMPLE ON AN ALTERNATE ADVIA CENTAUR XP INSTRUMENT AND RESULTS RECOVERED AS NON-REACTIVE. THE REPEAT NON-REACTIVE RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO AN INITIAL REACTIVE AHBS2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20532057 ↗
• MalfunctionOct 16, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT AN INITIAL REACTIVE ANTI-HEPATITIS B SURFACE ANTIGEN (AHBS2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE ADVIA CENTAUR XP ANALYZER. THE INITIAL REACTIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). INITIALLY, THE CUSTOMER REPEATED THE SAMPLE IN DUPLICATES ON THE ORIGINAL INSTRUMENT AND THE RESULTS RECOVERED AS REACTIVE AND NON-REACTIVE. THEN, THE CUSTOMER REPEATED THE SAME SAMPLE ON BOTH THE ORIGINAL AND ALTERNATE ADVIA CENTAUR XP INSTRUMENTS AND THE RESULTS RECOVERED AS NON-REACTIVE. THE REPEAT NON-REACTIVE RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INITIAL REACTIVE AHBS2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459716 ↗
• MalfunctionAug 6, 2024Use of Device Problem; Use of Device Problem

  AN OPERATOR OF AN ADVIA CENTAUR XP ANALYZER WAS SPLASHED IN THE EYE BY A DROP OF CONTROL MATERIAL. THE OPERATOR WAS MANUALLY SWIRLING THE CONTROL MATERIAL. THE OPERATOR FLUSHED HIS EYE WITH SALINE AND WILL SEEK FOLLOW TREATMENT LOCALLY. THE CONTROL MATERIAL WAS FOR RUBELLA OR HEPATITIS B (HBSAG). THE CUSTOMER IS SEEKING A PROCEDURE FOR HOW TO ADDRESS A POTENTIAL INFECTION FROM THE SPLASH. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT BEYOND FLUSHING THE EYE WITH SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920997 ↗
• MalfunctionMay 23, 2024Use of Device Problem; Imprecise or Erratic Results; Use of Device Problem; Imprecise or Erratic Results

  THE CUSTOMER REPORTED THAT MULTIPLE ERRONEOUS VITAMIN B12 (VB12) PATIENT RESULTS WERE GENERATED ON AN ADVIA CENTAUR XP ANALYZER. THE CUSTOMER HAD JUST MADE UP NEW DITHIOTHREITOL (DTT) SOLUTION FOR THE ASSAY PRIOR TO PROCESSING THE QUALITY CONTROLS (QC) AND PROCESSING THESE SAMPLES. THE CUSTOMER QUESTIONED ALL THE RESULTS AS THE QC THE FOLLOWING MORNING WAS UNACCEPTABLE AND DID NOT REPORT THEM TO THE PHYSICIAN(S). THE NEXT DAY, THE CUSTOMER MADE UP NEW DTT SOLUTION, RECALIBRATED THE ASSAY AND PROCESSED QC SUCCESSFULLY. THEN, THE CUSTOMER REPEATED THE SAMPLES AND CONSIDERED ALL THOSE RESULTS CORRECT, WHICH THEY REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS VB12 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19386481 ↗
• MalfunctionMay 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT THE ADVIA CENTAUR XP INSTRUMENT DISPLAYED CUVETTE PUSHER OFFLINE ERROR. WHILE TROUBLESHOOTING, THE OPERATOR SCRATCHED THEIR HAND WHILE OPENING THE COVER OF THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) WHILE TROUBLESHOOTING THE INSTRUMENT. THE OPERATOR IMMEDIATELY DISINFECTED THE SCRATCH WITH WATER AND SOAP AND CONTINUED THE TROUBLESHOOTING WEARING GLOVES. 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 19382827 ↗
• MalfunctionMar 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A NON-REACTIVE IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (AHCV) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE NON-REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT BASED ON THE PATIENT¿S HISTORICAL RESULT. THE SAMPLE WAS REPEATED THRICE ON AN ALTERNATE ADVIA CENTAUR XP INSTRUMENT AND SINCE TWO OF THE THREE RESULTS WERE GREATER THAN OR EQUAL TO 1.00 INDEX VALUE, THE SAMPLE WAS CONSIDERED REACTIVE. THE RESULT OF 1.03 INDEX WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THE SAMPLE WAS ALSO SENT TO AN ALTERNATE LABORATORY FOR TESTING ON AN ALTERNATE METHODOLOGY AND THE SAMPLE RECOVERED NON-REACTIVE FOR AHCV. THE SAME SAMPLE WAS SUBSEQUENTLY REPEATED ON ORIGINAL AND ALTERNATE INSTRUMENTS FOR TROUBLESHOOTING PURPOSES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NON-REACTIVE AHCV RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852369 ↗
• MalfunctionMar 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A NON-REACTIVE IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (AHCV) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE SAMPLE WAS REPEATED THRICE ON AN ALTERNATE ADVIA CENTAUR XP INSTRUMENT AND SINCE TWO OF THE THREE RESULTS WERE GREATER THAN OR EQUAL TO 1.00 INDEX VALUE, THE SAMPLE WAS CONSIDERED REACTIVE. THE RESULT OF 1.03 INDEX WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THE SAMPLE WAS ALSO SENT TO AN ALTERNATE LABORATORY FOR TESTING ON AN ALTERNATE METHODOLOGY AND THE SAMPLE RECOVERED NON-REACTIVE FOR AHCV. THE SAME SAMPLE WAS SUBSEQUENTLY REPEATED ON THE ORIGINAL AND ALTERNATE INSTRUMENTS FOR TROUBLESHOOTING PURPOSES. THIS PATIENT PERTAINS TO THE SAME PATIENT REFERENCED IN MDR: 2432235-2024-00044. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NON-REACTIVE AHCV RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852315 ↗
• MalfunctionFeb 23, 2024High Test Results; High Test Results

  FALSELY ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) RESULTS WERE GENERATED ON TWO PATIENT SAMPLES ON AN ADVIA CENTAUR XP ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPORTED THAT DUE TO THE ERRONEOUS RESULTS, THE PATIENTS WERE GIVEN DUAL ANTI-PLATELET TREATMENT AND ADMITTED TO THE ACCIDENT AND EMERGENCY DEPARTMENT, WHERE THEIR URINE AND ELECTROLYTES ROUTINE TESTS, LIVER FUNCTION, BONE PROFILE, C-REACTIVE PROTEIN (CRP) AND AMYLASE WERE EVALUATED. ADDITIONALLY, THESE PATIENTS WERE POTENTIALLY LISTED FOR AN ANGIOGRAM. THE CUSTOMER REPEATED THE SAMPLES, AND THE RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. THE CUSTOMER INDICATED THAT OTHER SAMPLES WERE POTENTIALLY IMPACTED BUT DID NOT PROVIDE THE ASSOCIATED DATA. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773179 ↗
• MalfunctionFeb 23, 2024High Test Results; High Test Results

  A FALSELY ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) RESULT WAS GENERATED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS ADMITTED TO THE ACCIDENT AND EMERGENCY DEPARTMENT, WHERE THEIR URINE AND ELECTROLYTES ROUTINE TESTS, LIVER FUNCTION, BONE PROFILE, C-REACTIVE PROTEIN (CRP) AND AMYLASE WERE EVALUATED. THE CUSTOMER REPEATED THE SAMPLE AND THE REPEAT RESULT RECOVERED LOWER THAN THE ERRONEOUS RESULT. THE CUSTOMER INDICATED THAT OTHER SAMPLES WERE POTENTIALLY IMPACTED BUT DID NOT PROVIDE THE ASSOCIATED DATA. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773161 ↗
• MalfunctionNov 30, 2023Low Test Results; Low Test Results

  FALSELY DEPRESSED CANCER ANTIGEN 19-9 (CA 19-9) RESULTS ON TWO PATIENT SAMPLES WERE OBTAINED ON AN ADVIA CENTAUR XP ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT WITH 1:10 DILUTION. THE SECOND REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTIONS OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA 19-9 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18240104 ↗
• MalfunctionNov 28, 2023Mechanical Problem; Mechanical Problem

  A CUSTOMER WAS SPLASHED IN THE EYE WITH FLUID WHILE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). THIS OCCURRED WHILE TROUBLESHOOTING A MONTHLY CLEANING PROCEDURE ON AN ADVIA CENTAUR XP INSTRUMENT. THE SOURCE OF THE FLUID WAS UNKNOWN AND AN EYE WASHER WAS USED FOR 15 MINUTES. CUSTOMER WAS EVALUATED BY THEIR EMPLOYEE HEALTH TEAM. IT WAS CONFIRMED THAT THERE WAS NO IMPACT TO PATIENTS AND NO DELAYS IN RESULTS. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221847 ↗
• MalfunctionNov 13, 2023High Test Results; High Test Results

  A FALSELY ELEVATED CANCER ANTIGEN CA 27.29 (BR) RESULT WAS OBTAINED ON A PATIENT SAMPLE AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS PROVIDED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE ERRONEOUS RESULT WAS HIGHER THAN THE PATIENT¿S HISTORICAL RESULT. SUBSEQUENTLY, THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND RECOVERED LOWER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S), AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BR RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124515 ↗
• MalfunctionAug 11, 2023High Test Results; High Test Results

  A FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. TWO DAYS LATER, THE SAMPLE WAS REPEATED ON THE INITIAL ADVIA CENTAUR XP INSTRUMENT. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS PROCESSED ON THE INITIAL INSTRUMENT, AND THE RESULT CORRELATED WITH THE REPEAT RESULT. THE RESULT FROM THE NEW SAMPLE WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510092 ↗
• MalfunctionJul 20, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result

  FALSE-LOW-POSITIVE HEPATITIS B SURFACE ANTIGEN (HBSII) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT. THE POSITIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER INDICATED THAT THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CENTAUR XP INSTRUMENT AND REPEAT RESULTS WERE NEGATIVE/NON-REACTIVE. THE NEGATIVE/NON-REACTIVE RESULTS WERE REPORTED. HOWEVER, THE CUSTOMER DID NOT PROVIDE THE REPEAT RESULTS FOR THESE SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW POSITIVE HBSII RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17363766 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041133. One submission often covers many models, so check the product and lot details in each record.

• Z-0720-2018 · Jul 28, 2017 · Terminated
  ADVIA Centaur T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and A
• Z-1615-2016 · Mar 30, 2016 · Terminated
  ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in
• Z-0859-2015 · Oct 9, 2014 · Terminated
  ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
• Z-0860-2015 · Oct 9, 2014 · Terminated
  ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
• Z-2716-2014 · Aug 19, 2014 · Terminated
  ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this syste
• Z-2715-2014 · Aug 19, 2014 · Terminated
  ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system a
• Z-2662-2014 · Aug 13, 2014 · Terminated
  ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968,
• Z-2663-2014 · Aug 13, 2014 · Terminated
  ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320757, 10323213, 10324519, 10327135, 103278