ADVIA Centaur® CP Immunoassay System 10309710Recalls & reported problems

Summary

The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 00630414523286), received between Jun 16, 2017 and Mar 30, 2026 — classified as 1 injury, 184 malfunctions.

The most frequently reported specific device problem is “High Test Results” (57 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 185 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS ERRONEOUS RELATIVE TO REPEAT TESTING WHEN USING LOT# 113 ON AN ADIVA CENTAUR CP ANALYZER (S/N:(B)(6)). AN INITIAL ELEVATED TNIH RESULT WAS OBSERVED FOR A PATIENT SAMPLE IN QUESTION. THE ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAME SAMPLE WAS THEN RETESTED ON THE ORIGINAL ANALYZER AND ALSO USING AN ALTERNATE METHODOLOGY WHICH PRODUCED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT, AND A CORRECTED REPORT WITH A RESULT OF 4.80 PG/ML WAS ISSUED 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 24737175 ↗
• MalfunctionDec 18, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON AN EMERGENCY ROOM (ER) PATIENT SAMPLE ON AN ADVIA CENTAUR CP ANALYZER. AN EMERGENCY ROOM (ER) PATIENT SAMPLE WAS INITIALLY TESTED, YIELDING A RESULT OF <3 PG/ML. THE PRIMARY TUBE WAS THEN RETESTED ON A NON-SIEMENS INSTRUMENT, WHICH PRODUCED A LOWER RESULT, THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). AFTER TWO HOURS, A NEW SAMPLE WAS DRAWN FROM THE ER PATIENT AND PROCESSED ON THE ORIGINAL ANALYZER. THE NEWLY DRAWN SAMPLE RESULT RECOVERED HIGHER THAN THE INITIALLY DRAWN SAMPLE AND WAS CONSIDERED ERRONEOUS. THE NEWLY DRAWN SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO DID NOT QUESTION THE RESULT. THE NEWLY DRAWN SAMPLE WAS SUBSEQUENTLY REPEATED IN TRIPLICATE ON THE ORIGINAL ANALYZER. THE REPEAT RESULTS RECOVERED LOWER THAN THE DISCORDANT RESULT AND WERE CONSIDERED CORRECT. THE MEAN OF REPEAT RESULTS WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER MENTIONED THAT THERE WAS NO TREATMENT PROVIDED OR DELAYED BASED ON THE ERRONEOUS RESULT AND THERE WAS NO DELAY IN REPORTING RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836310 ↗
• MalfunctionDec 5, 2025Battery Problem; Battery Problem

  THE CUSTOMER REPORTED AN ODOR EMANATING FROM THE UNINTERRUPTIBLE POWER SUPPLY (UPS) THAT THE ADVIA CENTAUR CP WAS PLUGGED INTO. A SMALL AMOUNT OF SMOKE WAS OBSERVED FROM THE UPS. THE ADVIA CENTAUR CP WAS NOT IN USE WHEN THE UPS OVER HEATED. THERE ARE NO REPORTS OF A DELAY IN TESTING, NO REPORTS OF DISCORDANT TEST RESULTS AND NO REPORTS OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732865 ↗
• MalfunctionDec 5, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR CP IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED ON ORIGINAL SYSTEM AND OBTAINED IMPRECISE RESULTS AND WERE CONSIDERED DISCORDANT. TWO HOURS LATER, A NEW SAMPLE WAS DRAWN AND TESTED ON THE ORIGINAL SYSTEM AND OBTAINED ERRONEOUS RESULT. THE NEWLY DRAWN SAMPLE WAS REPEATED ON THE ORIGINAL SYSTEM AND OBTAINED IMPRECISE RESULTS AND WERE CONSIDERED DISCORDANT. THE CUSTOMER MENTIONED THAT THEY HAD TO MOVE THE PATIENT SAMPLES TO ANOTHER PLATFORM FOR TROPONIN TESTING, HOWEVER THEY DID NOT HAVE ANY FURTHER RESULTS FROM THAT PLATFORM. THEREFORE, THE CORRECT RESULTS DATA TO THE SIEMENS IS UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725194 ↗
• MalfunctionDec 1, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT AN ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE ADVIA CENTAUR CP IMMUNOASSAY SYSTEM. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER). THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT ADMITTED TO THE ER SPECIFICALLY DUE TO THE ERRONEOUSLY ELEVATED TNIH RESULT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) BUT NOT QUESTIONED. THE SAMPLE WAS REPEATED TWICE ON THE ORIGINAL ANALYZER AND OBTAINED LOWER RESULTS, WHICH WERE CONSIDERED CORRECT, AND A RESULT OF 4.02 WAS REPORTED AS CORRECT RESULT TO THE PHYSICIAN. A CORRECTED REPORT WAS ISSUED. THE PATIENT WAS REDRAWN AND REPEATED ON THE ORIGINAL ADVIA CENTAUR ANALYZER AND OBTAINED A LOWER RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES, NO IMPACT ON PATIENT CARE, AND NO TREATMENT PROVIDED OR DELAYED DUE TO THE ERRONEOUSLY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677665 ↗
• MalfunctionNov 26, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A ADVIA CENTAUR CP. THE PATIENT HAD 3 TNIH SAMPLES COLLECTED. AFTER THE RESULT FROM SAMPLE 3 CORRELATED WITH SAMPLE 1, THE CUSTOMER RERAN SAMPLE 2 SINCE IT WAS INCONSISTENT WITH THE OTHER RESULTS. THE CUSTOMER RECENTRIFUGED SAMPLE 2 AND OBTAINED A LOWER TEST RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657365 ↗
• MalfunctionOct 29, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON 2 PATIENT SAMPLES ON ADVIA CENTAUR CP IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE PATIENTS WERE REDRAWN ONE HOUR LATER AND TESTED ON AN ALTERNATE ADVIA CENTAUR XPT IMMUNOASSAY SYSTEM. THE REDRAWN SAMPLE RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. THE REDRAWN SAMPLE RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE INITIAL SAMPLE FOR PATIENT WITH SAMPLE IDENTIFIER (B)(6) WAS TESTED AGAIN ON THE INITIAL ADVIA CENTAUR CP IMMUNOASSAY SYSTEM AND OBTAINED A LOWER RESULT. 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 23413871 ↗
• MalfunctionAug 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED TOTAL HCG (THCG) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE WHEN PROCESSED ON AN ADVIA CENTAUR CP ANALYZER, SERIAL NUMBER (S/N): (B)(6). THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THE ELEVATED WAS QUESTIONED BY THE PHYSICIAN SINCE THE PATIENT WAS NOT EXPECTED TO BE PREGNANT. THE SAME SAMPLE WAS THEN REPROCESSED ON THE ORIGINAL AND AN ALTERNATE ANALYZER (ADVIA CENTAUR XPT) WHICH PRODUCED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT AND THE LOWER RESULT OBTAINED ON THE ALTERNATE ANALYZER WAS ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. ADDITIONALLY, THE PATIENT WAS ALSO TESTED FOR A URINE HCG WHICH OBTAINED A NEGATIVE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22780633 ↗
• MalfunctionJun 13, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT FALSELY DEPRESSED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR CP ANALYZER. THE FIRST AUTO DILUTED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED THRICE ON THE ORIGINAL ANALYZER, SIMILAR RESULTS WERE OBTAINED AND CONSIDERED ERRONEOUS. THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CENTAUR CP ANALYZER. THE REPEAT RESULT OBTAINED WAS HIGHER AND REPORTED AS CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201429 ↗
• MalfunctionJun 9, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT ERRONEOUSLY DEPRESSED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WITH AN OVER-PRESSURE ERROR MESSAGE WERE OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR CP ANALYZER. INITIALLY, THE CUSTOMER RAN THE PATIENT SAMPLE AND RECEIVED AN OVER-PRESSURE ERROR. THE SAMPLE WAS AUTO-REPEATED AND OBTAINED A ABOVE THE ASSAY RANGE RESULT. SUBSEQUENTLY, THE SAMPLE WAS AUTO-DILUTED, WHICH AGAIN RESULTED IN AN OVER-PRESSURE ERROR. THE AUTO-DILUTED RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THEN THE SAMPLE WAS REPEATED THRICE ON THE ORIGINAL ANALYZER, AND THE RESULTS RECOVERED HIGHER THAN THE AUTO-DILUTED RESULT WITH OVER-PRESSURE ERROR. THE SAMPLE WAS REPEATED A SECOND TIME ON AN ALTERNATE ADVIA CENTAUR CP ANALYZER, AND THE RESULT RECOVERED HIGHER THAN THE AUTO-DILUTED RESULT WITHOUT AN OVER-PRESSURE ERROR. THE REPEAT RESULT OBTAINED ON THE ALTERNATE ANALYZER 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 ERRONEOUSLY DEPRESSED THCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165552 ↗
• MalfunctionMay 23, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ADVIA CENTAUR CP ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). FOR THE FIRST PATIENT, TWO NEW SAMPLES WERE DRAWN AT DIFFERENT TIMES AND PROCESSED ON THE ORIGINAL ANALYZER, WHICH RECOVERED LOWER THAN THE INITIAL RESULT. BOTH THE SECOND AND THIRD DRAWN SAMPLE RESULTS WERE CONSIDERED CORRECT. THEN, THE CUSTOMER REPEATED THE ORIGINAL SAMPLE ON THE ORIGINAL ANALYZER AND OBTAINED A SIMILAR LOWER RESULT, WHICH WAS CONSIDERED CORRECT. THE RESULT OF 21.0 PG/ML WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). FOR THE SECOND PATIENT, THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CENTAUR XP 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 TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076784 ↗
• MalfunctionApr 25, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE WHEN PROCESSED ON AN ADVIA CENTAUR CP ANALYZER. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. 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 ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. FOR TROUBLESHOOTING PURPOSES, A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND TESTED ON AN ALTERNATE ADVIA CENTAUR XP INSTRUMENT AND OBTAINED A SIMILAR LOWER RESULT. 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 21907543 ↗
• MalfunctionAug 22, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR CP IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). TWO HOURS LATER, THE PATIENT¿S BLOOD WAS REDRAWN, AND THE NEW SAMPLE WAS PROCESSED ON THE SAME INSTRUMENT. THE RESULT WAS INCONSISTENT WITH THE PRIOR SAMPLE RESULT. THEN, THE LATTER SAMPLE WAS REPEATED IN DUPLICATE ON THE ORIGINAL INSTRUMENT AND THE REPEAT RESULTS RECOVERED HIGHER. NEXT, THE FIRST SAMPLE WAS REPEATED ON THE ORIGINAL INSTRUMENT AND THE SAMPLE RECOVERED LOWER. THEN, BOTH SAMPLES WERE REPEATED ON THE NON-SIEMENS INSTRUMENT AND RECOVERED LOWER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULTS FROM THE NON-SIEMENS INSTRUMENT WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER MENTIONED THAT INCONSISTENT TNIH RESULTS WERE OBTAINED ON SAMPLES FROM OTHER PATIENTS BUT DID NOT PROVIDE THE ASSOCIATED PATIENT DATA. 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 20042737 ↗
• MalfunctionMay 15, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT THAT WAS OBTAINED ON 1 PATIENT SAMPLE ON A ADVIA CENTAUR CP INSTRUMENT. THE ERRONEOUS TNIH RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS REDRAWN, AND THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT. THE INITIAL SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND OBTAINED THE SAME INITIAL VALUE. THE REPEAT 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 FALSELY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319224 ↗
• MalfunctionApr 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A PROGESTERONE (PRGE) RESULT OF 6.0 NG/ML WAS GENERATED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR CP INSTRUMENT. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND RECOVERED LOWER THAN THE INITIAL RESULT. SUBSEQUENTLY, THE CUSTOMER SENT THE SAMPLE OUT FOR TESTING. THE CUSTOMER DID NOT PROVIDE THE RESULTS FROM THE ALTERNATE LABORATORY. ADDITIONALLY, THE CUSTOMER REPORTED THERE WAS DELAY IN TESTING OF ABOUT TWO DAYS FOR TOTAL HUMAN CHORIONIC GONADOTROPIN (TOTAL HCG) DUE TO ISSUES WITH QUALITY CONTROL RECOVERIES. FURTHERMORE, THE CUSTOMER INDICATED THAT THEY OBTAINED DISCORDANT ENHANCED ESTRADIOL (EE2) RESULTS BUT DECLINED TO PROVIDE ANY FURTHER INFORMATION. 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 19099272 ↗
• MalfunctionMar 28, 2024Smoking; Smoking

  THE CUSTOMER REPORTED CUVETTE JAM ON THE ADVIA CENTAUR CP INSTRUMENT. THE CUSTOMER NOTICED SMOKE EMITTED FROM BACK OF THE CUVETTE HOPPER AREA OF THE INSTRUMENT AND BURNING SMELL. THE CUSTOMER SUBSEQUENTLY TURNED OFF THE INSTRUMENT. THE CUSTOMER STATED THAT THERE WERE NO VISIBLE FLAMES ASSOCIATED WITH THE EVENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993108 ↗
• MalfunctionFeb 8, 2024High Test Results; High Test Results

  A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) PATIENT RESULT WAS OBTAINED ON AN ADVIA CENTAUR CP INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED THE SAME INSTRUMENT AND AN ALTERNATE ADVIA CENTAUR CP TO PERFORM REPEAT. THE CUSTOMER OBTAINED SIMILAR LOWER RESULTS ON BOTH INSTRUMENTS. THE REPEAT RESULTS WERE CONSIDERED CORRECT, AND A CORRECTED REPORT WAS 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 18670829 ↗
• MalfunctionJan 25, 2024High Test Results; High Test Results

  A FALSELY ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR CP INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWICE ON THE ORIGINAL INSTRUMENT. THE REPEAT RESULTS RECOVERED LOWER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT OF 8.05 NG/ML WAS REPORTED TO THE PHYSICIAN(S) AS CORRECT RESULT. ON (B)(6) 2024, THE CUSTOMER SENT OUT THE SAME SAMPLE TO A REFERENCE LAB FOR TESTING, AND THE SAMPLE RECOVERED WITH 7.0 NG/ML AND 7.0 NG/ML WAS CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584344 ↗
• MalfunctionDec 28, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISCORDANT HUMAN CHORIONIC GONADOTROPIN (THCG) PATIENT RESULT WAS OBTAINED ON AN ADVIA CENTAUR CP INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. IT IS UNKNOWN IF THE REPEAT RESULT WAS CONSIDERED THE CORRECT RESULT AND REPORTED TO THE PHYSICIAN(S). 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 18408821 ↗
• MalfunctionDec 27, 2023High Test Results; High Test Results

  FALSELY ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON AN ADVIA CENTAUR CP INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE ADVIA CENTAUR CP INSTRUMENT. THE REPEAT RESULTS RECOVERED LOWER THAN THE ERRONEOUS RESULTS. 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 TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400185 ↗
• MalfunctionOct 19, 2023High Test Results; High Test Results

  A NEGATIVE TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR CP INSTRUMENT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, WHICH RECOVERED FALSELY ELEVATED. THE SAMPLE WAS SENT TO THE MAIN LAB AND REPEATED ON AN ALTERNATE ATELLICA ANALYZER, WHICH RECOVERED LOWER THAN THE ERRONEOUS RESULT. ON THE SUBSEQUENT DAY, THE SAMPLE WAS REPEATED ON THE INITIAL ADVIA CENTAUR CP INSTRUMENT, AND THE RESULT CORRELATED WITH THE RESULT OBTAINED ON THE ATELLICA IM ANALYZER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS THCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17970121 ↗
• MalfunctionAug 24, 2023High Test Results; High Test Results

  A FALSELY ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR CP ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). A SECOND SAMPLE FROM THE PATIENT WAS DRAWN AND RUN ONE HOUR LATER FOR TNIH ON THE ADVIA CENTAUR CP ANALYZER, RECOVERING LOWER. AFTER RECEIVING THE RESULT FROM THE SECOND SAMPLE, THE PHYSICIAN(S) QUESTIONED THE ERRONEOUS RESULT. THE INITIAL SAMPLE WAS THEN RERUN FOR TNIH ON THE ADVIA CENTAUR CP ANALYZER AS WELL AS ON AN ADVIA CENTAUR XP ANALYZER, BOTH TIMES RECOVERING LOWER THAN THE INITIAL RESULT. THE LOWER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). A THIRD SAMPLE FROM THE PATIENT WAS THEN RUN FOR TNIH ON THE ADVIA CENTAUR CP ANALYZER, ALSO RECOVERING LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618993 ↗
• MalfunctionJun 28, 2023High Test Results; High Test Results

  FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON FIVE PATIENT SAMPLES ON AN ADVIA CENTAUR CP INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE INITIAL ADVIA CENTAUR CP INSTRUMENT. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. 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 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215757 ↗
• MalfunctionMay 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ERRONEOUS TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ADVIA CENTAUR CP INSTRUMENT. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. 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 ERRONEOUS THCG PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976480 ↗
• MalfunctionMay 18, 2023High Test Results; High Test Results

  A FALSELY ELEVATED INTACT PARATHYROID HORMONE (PTH) RESULT WAS OBTAINED ON A SAMPLE ON AN ADVIA CENTAUR CP INSTRUMENT FOR A PATIENT UNDERGOING PARATHYROID SURGERY. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED MULTIPLE TIMES AND THE REPEAT RESULTS RECOVERED LOWER THAN THE INITIAL RESULT. THE RESULT OF 51.8 PG/ML WAS REPORTED TO THE PHYSICIAN, AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS PTH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955725 ↗

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-0860-2015 · Oct 9, 2014 · Terminated
  ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
• Z-0859-2015 · Oct 9, 2014 · Terminated
  ADVIA Centaur (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-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