ADVIA Centaur® XPT Analyzer 10711433Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 00630414596914), received between Oct 16, 2017 and Feb 20, 2026 — classified as 192 malfunctions.

The most frequently reported specific device problem is “High Test Results” (62 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 192 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026High Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY ELEVATED TROPONIN (TNIH) TEST RESULT WAS OBTAINED FROM AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL TEST RESULT WAS NOT RELEASED TO A PHYSICIAN. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CENTAUR XPT ANALYZER. A LOWER TEST RESULT WAS OBTAINED AND RELEASED TO A PHYSICIAN AS THE CORRECT RESULT. THE PATIENT WAS RECEIVING AN IMMUNOTHERAPY TREATMENT AT TIME OF THE SAMPLE COLLECTION. 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 24406301 ↗
• MalfunctionOct 31, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF ELEVATED TOTAL HCG (THCG) RESULTS ON FIVE PATIENT SAMPLES ON AN ADVIA CENTAUR XPT ANALYZER (S/N: (B)(6). THE INITIAL ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) BUT WERE NOT QUESTIONED. THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CENTAUR XPT ANALYZER. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULTS AND WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439194 ↗
• MalfunctionAug 7, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XPT ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ORIGINAL ANALYZER. THE REPEAT RESULT RECOVERED LOWER THAN THE INITIAL RESULT AND WAS CONSIDERED CORRECT. THE REPEAT RESULT 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 22735646 ↗
• MalfunctionJul 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUS HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS ON MORE THAN TWENTY PATIENT SAMPLES AND TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS ON APPROXIMATELY TEN PATIENT SAMPLES ON AN ADVIA CENTAUR XPT ANALYZER. HOWEVER, THE CUSTOMER ONLY PROVIDED 3 SAMPLE RESULTS DATA FOR TNIH AND 2 SAMPLE RESULTS DATA FOR THCG AND DECLINED TO PROVIDE FURTHER PATIENT RESULTS DATA TO SIEMENS. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CENTAUR CP ANALYZER. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS TNIH AND THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530166 ↗
• MalfunctionJul 3, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XPT ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CENTAUR CP IMMUNOASSAY SYSTEM THE SAME ADVIA CENTAUR XPT ANALYZER. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULT. 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 FALSELY ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396028 ↗
• MalfunctionJun 20, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTED OBSERVATION OF A NONREACTIVE (NEGATIVE) ADVIA CENTAUR HEPATITIS B SURFACE ANTIGEN (HBSAGII (HBSII)) RESULT, WHICH WAS CONSIDERED DISCORDANT WHEN USING HBSAG LOT# 315. AN INITIAL REACTIVE RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION ON AN ALTERNATE ADVIA CENTAUR XPT ANALYZER. PER THE ASSAY¿S INSTRUCTIONS FOR USE (IFU), ¿SAMPLES WITH AN INDEX VALUE OF GREATER THAN OR EQUAL TO 1.0 BUT LESS THAN OR EQUAL TO 50 ARE CONSIDERED REACTIVE (POSITIVE) FOR HBSAG. THE TEST MUST BE REPEATED IN DUPLICATE. IF 2 OF THE 3 RESULTS ARE NONREACTIVE (NEGATIVE), THE SAMPLE IS CONSIDERED NEGATIVE FOR HBSAG. FOLLOWING THE IFU, THE CUSTOMER RECENTRIFUGED AND REPEATED THE SAMPLE IN DUPLICATES ON THE SAME ALTERNATE INSTRUMENT AND OBTAINED REACTIVE RESULTS. HOWEVER, THE REACTIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE IFU ALSO STATES ¿IF AT LEAST 2 OF THE 3 RESULTS ARE REACTIVE (POSITIVE), THE SAMPLE IS REPEATEDLY REACTIVE (POSITIVE), AND THE PRESENCE OF HBSAG SHOULD BE CONFIRMED WITH THE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY, ADDITIONAL HBV MARKER ASSAYS, OR ANOTHER APPROVED CONFIRMATORY METHOD.¿ IN ACCORDANCE WITH THE LABORATORY¿S INTERNAL STANDARD OPERATING PROCEDURE (SO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296009 ↗
• MalfunctionJun 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) AND TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CENTAUR CP ANALYZER. THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULTS, WHICH WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). 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 22283476 ↗
• MalfunctionJun 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSE POSITIVE TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON SIX PATIENT SAMPLES ON AN ADVIA CENTAUR XPT ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE ORIGINAL ANALYZER WITH NEW REAGENT PACK. THE REPEAT RESULTS RECOVERED NEGATIVE. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S) AS THEY WERE CONSISTENT WITH THE PATIENT¿S CLINICAL HISTORY. THERE ARE NO KNOWN REPORTS OF DELAY, PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22226194 ↗
• MalfunctionMay 16, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CENTAUR CP ANALYZER, AND A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER TESTED ANOTHER URINE THCG SAMPLE ON THE ORIGINAL ANALYZER, AND THE RESULT WAS NEGATIVE. THE NEGATIVE RESULTS WERE CONSIDERED CORRECT, AND THE RESULT OF 2.9 MIU/ML WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034419 ↗
• MalfunctionMay 9, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CENTAUR CP ANALYZER. THE REPEAT RESULT RECOVERED LOWER THAN THE INITIAL RESULT AND WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996210 ↗
• MalfunctionApr 21, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT FALSE POSITIVE RESULTS FOR INFECTIOUS DISEASE ASSAYS WERE OBTAINED ON THE ADVIA CENTAUR XPT ANALYZER WITH SERIAL NUMBER: (B)(6) AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED ON AN ALTERNATE ANALYZER, THE REPEAT RESULTS WERE NEGATIVE, CONSIDERED CORRECT, AND THAT CORRECTED REPORTS WERE ISSUED. 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 21876229 ↗
• MalfunctionApr 2, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED RUNNING HIGH-SENSITIVITY TROPONIN I (TNIH) IN TRIPLICATE, OBSERVING A TNIH FALSELY ELEVATED RESULT ON THE ADVIA CENTAUR XPT ANALYZER, AND NOT REPORTING THE RESULT TO THE PHYSICIAN(S). THE CUSTOMER USED AN ALTERNATE ADVIA CENTAUR XPT ANALYZER TO PERFORM REPEAT TESTING, RAN THE SAME SAMPLE IN TRIPLICATE, AND NOTED THAT THE REPEAT RESULTS WERE CONSISTENT AND CONSIDERED CORRECT. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750840 ↗
• MalfunctionMar 10, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUS TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES WHEN PROCESSED ON AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ANALYZER. THE REPEAT RESULTS WERE CONSIDERED AND WERE REPORTED TO THE PHYSICIAN(S). 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 21557761 ↗
• MalfunctionMar 10, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUS TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES WHEN PROCESSED ON AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ANALYZER. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). 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 21557756 ↗
• MalfunctionMar 10, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE WHEN PROCESSED ON AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER AND OBTAINED A HIGHER RESULT. THE HIGHER RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21557751 ↗
• MalfunctionMar 10, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUS TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES WHEN PROCESSED ON AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ANALYZER. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). 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 21557743 ↗
• MalfunctionMar 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES WHEN PROCESSED ON AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ANALYZER AND OBTAINED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21557695 ↗
• MalfunctionMar 10, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE WHEN PROCESSED ON AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER AND OBTAINED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN. THERE IS 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 21557693 ↗
• MalfunctionFeb 24, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON EIGHT PATIENT SAMPLES ON AN ADVIA CENTAUR XPT ANALYZER. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND AN ALTERNATE ADVIA CENTAUR ANALYZER. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS OBTAINED ON THE ALTERNATE ADVIA CENTAUR ANALYZER FOR 7 PATIENT SAMPLES WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE REPEAT RESULT FROM THE INITIAL INSTRUMENT OBTAINED FOR PATIENT IDENTIFIED WITH SAMPLE ID: (B)(6) 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 FALSELY ELEVATED TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21452915 ↗
• MalfunctionFeb 21, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPROCESSED ON AN ORIGINAL ANALYZER AND OBTAINED LOWER RESULTS. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431370 ↗
• MalfunctionFeb 20, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON THREE (3) PATIENT SAMPLES WHEN PROCESSED ON AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ANALYZER AND OBTAINED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT SINCE IT MATCHED THE CLINICAL HISTORY OF THE PATIENTS AND WERE REPORTED TO THE PHYSICIAN(S). THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419151 ↗
• MalfunctionFeb 13, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE WHEN PROCESSED ON AN ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER AND OBTAINED A LOWER RESULT. THE LOWER RESULT WAS CONSIDERED CORRECT SINCE IT MATCHED THE CLINICAL HISTORY OF THE PATIENT AND WAS REPORTED TO THE PHYSICIAN. 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 21374933 ↗
• MalfunctionJan 30, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE ADVIA CENTAUR XPT ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS REDRAWN, AND THE REDRAWN SAMPLE WAS PROCESSED ON THE ORIGINAL ANALYZER. ON THE SUBSEQUENT DAY, THE ORIGINAL SAMPLE WAS REPROCESSED ON THE ORIGINAL ANALYZER. THE REPEAT RESULTS OBTAINED FROM BOTH SAMPLES WERE <1 MIU/ML. THE REPEAT RESULTS WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO A FALSELY ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271925 ↗
• MalfunctionJan 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON A PRIMARY PATIENT SAMPLE AND ON AN ALIQUOT OF THE SAME PATIENT SAMPLE ON AN ADVIA CENTAUR XPT ANALYZER. THESE SAMPLES WERE PROCESSED AT THE SAME TIME AND THE RESULTS (63.10 NG/L AND 184.39 NG/L, RESPECTIVELY) WERE NOT REPORTED TO THE PHYSICIAN(S). THE PRIMARY SAMPLE AND ALIQUOT WERE REPEATED MULTIPLE TIMES ON THE SAME ADVIA CENTAUR XPT ANALYZER. THE REPEAT RESULTS WERE LOWER THAN THE INITIAL RESULTS. THE CUSTOMER DID NOT REPORT THE RESULTS AND REQUESTED A NEW SAMPLE DRAW FROM THE PATIENT. THE CORRECT RESULT FOR THIS PATIENT IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21255210 ↗
• MalfunctionNov 25, 2024Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT WHILE TROUBLESHOOTING THE ADVIA CENTAUR XPT IMMUNOASSAY SYSTEM, THE OPERATOR OPENED THE WASTE FLUIDIC DRAWER, AND THE LIQUID WAS SPRAYED ON HIS FOREHEAD FROM THE WASTE TUBING, WHICH WAS LOOSENED. THE OPERATOR STATED THAT NO LIQUID WENT TO HIS EYES. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) EXCEPT THE GOGGLES. AFTER THE OPERATOR WAS SPLASHED, HE WENT TO THE EYEWASH STATION AND RINSED HIS FOREHEAD WITH WATER, AND HE DID NOT SEEK ANY FURTHER MEDICAL INTERVENTION. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770385 ↗

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-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-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-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
• 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,