ADVIA Centaur XP AnalyzerRecalls & reported problems across all models
Siemens Healthcare Diagnostics Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 269
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of ADVIA Centaur XP Analyzer by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 269 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2017 and Apr 2, 2026 — classified as 269 malfunctions.
The most frequently reported specific device problem is “High Test Results” (53 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
Reports received per month, all models
Most reported ADVIA Centaur XP Analyzer problems
Device problems
- High Test Results53
- Incorrect, Inadequate or Imprecise Result or Readings44
- Mechanical Problem40
- False Positive Result29
- Adverse Event Without Identified Device or Use Problem19
- No Apparent Adverse Event14
- False Negative Result11
- Low Test Results11
Patient problems
- No Known Impact Or Consequence To Patient161
- No Clinical Signs, Symptoms or Conditions106
- Eye Injury1
- Laceration(s)1
- Patient Problem/Medical Problem1
ADVIA Centaur XP Analyzer models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ADVIA Centaur® XP Analyzer 10364455ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE243 reports
- ADVIA Centaur® XP Analyzer 10471899ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE26 reports
Recent ADVIA Centaur XP Analyzer adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Siemens Healthcare Diagnostics Inc. products
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- Atellica IM CA 19-93 models · 121 reports · 3 recalls
- ADVIA Centaur CA 19-92 models · 124 reports · 2 recalls
- Atellica IM eE23 models · 65 reports · 3 recalls
- RAPIDPoint 500 Measurement Cartridge4 models · 3 reports · 4 recalls
- ADVIA Centaur eE23 models · 22 reports · 3 recalls
- Atellica IM Fol3 models · 10 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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