ADVIA Centaur® XP Analyzer 10471899Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00630414585475), received between Jul 7, 2017 and Mar 17, 2023 — classified as 26 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2023High Test Results; High Test Results

  A FALSELY ELEVATED VITAMIN B12 (VB12) RESULT WAS GENERATED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND RECOVERED LOWER THAN THE ERRONEOUS RESULT. THE CUSTOMER WAS CONFIDENT WITH REPEAT RESULT AS IT CORRELATED WITH THE RESULTS RETESTED AT OTHER REFERENCE LAB AND OTHER BRANCH OF SAME CENTER. 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 VB12 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567845 ↗
• MalfunctionNov 15, 2022Temperature Problem; Temperature Problem

  THE CUSTOMER OBSERVED AN ANCILLARY QUEUE LOOP OUT OF TOLERANCE THERMAL ERROR AND A BURNING SMELL FROM THE ANCILLARY QUEUE AREA OF THE ADVIA CENTAUR XP ANALYZER, CAUSING A DELAY IN TESTING PATIENT SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798354 ↗
• MalfunctionOct 11, 2021High Test Results; High Test Results

  THE CUSTOMER INFORMED SIEMENS OF DISCORDANT FALSELY ELEVATED ALPHA-FETOPROTEIN (AFP) RESULTS OBTAINED ON THE ADVIA CENTAUR XP INSTRUMENT. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED THE SAME PATIENT SAMPLES AND AN ALTERNATE ADVIA CENTAUR TO PERFORM REPEAT TESTING. THE CUSTOMER NOTED THE REPEAT RESULTS WERE LOWER AND CONSIDERED TO BE CORRECT RESULTS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED AFP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12611516 ↗
• MalfunctionJun 3, 2021Sparking; Sparking

  WHILE TROUBLESHOOTING A WASTE PINCH VALVE ON AN ADVIA CENTAUR XP, A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) OBSERVED THAT A SHORT/SPARKS WERE EMITTED FROM THE INSTRUMENT. WHEN THE VALVE WAS BEING REPAIRED, WORN WIRES ON THE PINCH VALVES TOUCHED, CAUSING THE SPARK. THE CSE DID NOT CONTACT THE SPARK AND THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES, SMOKE, FLAMES, OR INJURIES DUE TO THIS EVENT. THE CSE DID NOT REQUIRE MEDICAL ATTENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11932615 ↗
• MalfunctionMay 5, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSE ELEVATED ENHANCED ESTRADIOL (EE2) RESULT ON AN ADVIA CENTAUR XP INSTRUMENT. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED THE SAME SAMPLE TO PERFORM REPEAT TESTING ON AN ALTERNATE ADVIA CENTAUR XP INSTRUMENT AND OBSERVED A LOWER RESULT. THE CUSTOMER NOTED THAT REPEAT RESULT WAS CORRECT BASED ON THE PERFORMANCE OF THE ALTERNATE INSTRUMENT, CLINICAL DETAILS, AND OTHER TESTS PERFORMED. THE CORRECT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE ELEVATED EE2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11779738 ↗
• MalfunctionFeb 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISCORDANT HIGH CARDIAC TROPONIN PATIENT RESULT WAS OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. 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 DISCORDANT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9678531 ↗
• MalfunctionOct 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A (B)(6) PATIENT RESULT WAS OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLE WAS REPEATED THREE TIMES ON AN ALTERNATE INSTRUMENT. THE REPEATED RESULTS WERE REPORTED, TO THE PHYSICIAN(S). PHYSICIAN(S) WAS UNSURE OF THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9216358 ↗
• MalfunctionSep 24, 2019Use of Device Problem; Use of Device Problem

  THE OPERATOR NOTICED THAT A CONNECTION FROM THE ADVIA CENTAUR XP WASTE BOTTLE WAS BROKEN AND CAUSED WASTE FLUID TO LEAK ON THE FLOOR. THE OPERATOR CLEANED THE LEAK AND GOT SOME FLUID ON THEIR SKIN. THE SKIN BECAME RED AND IRRITATED, AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND CLAIMED NO SERIOUS HARM. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE LEAK AND EXPOSURE TO WASTE FLUID.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9111344 ↗
• MalfunctionJun 28, 2019False Positive Result; False Positive Result

  A DISCORDANT (POSITIVE) TOTAL HUMAN CHORIONIC GONADOTROPIN (TOTAL HCG) RESULT WAS OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN(S) AT THE FERTILITY TREATMENT CENTER. THE SAME SAMPLE AND INSTRUMENT WERE USED TO PERFORM REPEAT TESTING. THE REPEAT RESULT WAS LOWER (NEGATIVE) AND MATCHED WITH THE EXPECTATIONS FOR THE PATIENT. THE CUSTOMER ISSUED A CORRECTED REPORT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOTAL HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8743969 ↗
• MalfunctionMay 10, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT DISCORDANT THYROID-STIMULATING HORMONE 3-ULTRA (TSH3-UL) AND FREE TRIIODOTHYRONINE (FT3) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND SOME PHYSICIAN(S) QUESTIONED THE RESULTS. THE CUSTOMER PROVIDED THE DISCORDANT, FALSELY LOW TSH3-UL RESULT OBTAINED ON ONE PATIENT SAMPLE. THE CUSTOMER REPORTED THAT BASED ON THE DISCORDANT, FALSELY LOW TSH3-UL RESULT, THE PATIENT WAS DIAGNOSED WITH GRAVE'S DISEASE AND WAS PRESCRIBED MEDICATION. THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CENTAUR INSTRUMENT, RESULTING HIGHER. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S), AND THE MEDICATION ORDER WAS CANCELLED. THE CUSTOMER DID NOT PROVIDE THE TEST RESULTS OBTAINED ON THE OTHER PATIENT SAMPLES, BUT INDICATED THAT SOME RESULTS NEEDED TO BE CORRECTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-UL AND FT3 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8601833 ↗
• MalfunctionFeb 8, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED MULTIPLE TIMES RESULTING LOWER. THE RESULT OF <2.0 MIU/ML WAS REPORTED TO THE PHYSICIAN(S) AS A CORRECTED RESULT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED THCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8322263 ↗
• MalfunctionFeb 8, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE REPEAT RESULT WAS DISCORDANT BUT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED MULTIPLE TIMES. THE RESULT OF 48.0 MIU/ML WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED THCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8322254 ↗
• MalfunctionJul 30, 2018Imprecision; Imprecision

  THE CUSTOMER INFORMED SIEMENS OF (B)(6) DISCORDANT RESULTS OBTAINED ON THE ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED THE SAME SAMPLE AND INSTRUMENT TO PERFORM REPEAT TESTING. REPEATED TEST RESULTS WERE LOWER (NONREACTIVE), AND THE CUSTOMER STATED THAT RESULTS DID NOT MATCH PREVIOUS RESULTS. THE CUSTOMER DID NOT PROVIDE ADDITIONAL INFORMATION, AND IT IS UNKNOWN IF DISCORDANT RESULTS ARE (B)(6) OR (B)(6). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT (B)(6) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7733311 ↗
• MalfunctionJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT (B)(6) SURFACE ANTIGEN II RESULT ((B)(6)) WAS OBTAINED ON A PATIENT ON AN ADVIA CENTAUR XP INSTRUMENT. THE SAMPLE HAD INITIALLY RESULTED (B)(6) AND UPON REPEAT TESTING WAS (B)(6). A CONFIRMATORY (B)(6) TEST WAS PERFORMED ON THE SAME INSTRUMENT, WHICH RESULTED (B)(6). NONE OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7616111 ↗
• MalfunctionMay 18, 2018Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER INFORMED SIEMENS OF TWO PATIENT SAMPLE RESULTS THAT WERE TRANSFERRED TO THE LABORATORY INFORMATION SYSTEM (LIS) HOST COMPUTER AND DISPLAYED INCORRECT RESULTS. THE INITIAL RESULTS OBTAINED ON THE ADVIA CENTAUR XP INSTRUMENT WERE TRANSFERRED TO THE LIS AND THE RESULTS, DISPLAYED ON THE HOST COMPUTER, WERE DIFFERENT AND SOME INCLUDED NON-NUMERICAL VALUES. THE PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). REPEAT TESTING WAS NOT PERFORMED TO CONFIRM CORRECT RESULTS.THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527559 ↗
• MalfunctionMay 2, 2018Mechanical Problem; Mechanical Problem

  A DISCORDANT (B)(6) ANTIBODIES TO (B)(6) PATIENT SAMPLE TEST RESULT WAS OBTAINED FROM AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL TEST RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED THREE TIMES ON THE SAME INSTRUMENT GIVING A (B)(6) TEST RESULT EACH TIME. THE (B)(6) TEST RESULT IS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE (B)(6) TEST RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7480916 ↗
• MalfunctionMay 2, 2018Mechanical Problem; Mechanical Problem

  A DISCORDANT, FALSE REACTIVE RESULT FOR ASSAY FOR THE DETECTION OF IGG ANTIBODIES TO TOXOPLASMA GONDII (TOXO G) WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS TESTED IN ANOTHER LABORATORY AND THE RESULT FOR TOXO G WAS NONREACTIVE. THE PATIENT QUESTIONED THE INITIAL RESULT AND THE CUSTOMER REPEATED THE SAMPLE ON THE SAME INSTRUMENT, WHICH RESULTED NONREACTIVE. THE NONREACTIVE RESULT WAS REPORTED AS A CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSE REACTIVE TOXO G RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7479822 ↗
• MalfunctionApr 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY ELEVATED TOTAL HUMAN CHORIONIC GONADOTROPIN (TOTAL HCG) RESULT WAS OBTAINED ON AN ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN(S). THE CUSTOMER USED THE SAME SAMPLE AND INSTRUMENT TO PERFORM REPEAT TESTING. THE DILUTED AND UNDILUTED TEST RESULTS WERE <2 AND A CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE TOTAL HCG DISCORDANT PATIENT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7473559 ↗
• MalfunctionApr 18, 2018Mechanical Problem; Mechanical Problem

  A DISCORDANT, FALSELY LOW TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE ADVIA CENTAUR XP INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS RERUN, AT MULTIPLE DILUTIONS, ON AN ALTERNATE ADVIA CENTAUR INSTRUMENT, RESULTING HIGHER. THE 3RD 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 DISCORDANT, FALSELY LOW THCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441102 ↗
• MalfunctionApr 13, 2018Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY LOW TOTAL HUMAN CHORIONIC GONADOTROPIN (THCG) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE PATIENT SAMPLE WAS TESTED IN ANOTHER LABORATORY, WHICH GAVE POSITIVE RESULT FOR HUMAN CHORIONIC GONADOTROPIN. THE CUSTOMER REPEATED THE SAMPLE ON THE SAME INSTRUMENT AND ALTERNATE ADVIA CENTAUR XP INSTRUMENT, RESULTING HIGHER. THE CORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW THCG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7428421 ↗
• MalfunctionFeb 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW CA19-9 RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULTS WERE OBTAINED WHEN THE SAMPLE WAS DILUTED ON BOARD BY THE INSTRUMENT. ONE OF THE FALSELY LOW RESULTS WAS REPORTED TO PHYSICIAN(S). THE SAME SAMPLE WAS TESTED ON AN ALTERNATE ADVIA CENTAUR XP AND RESULTED HIGHER ON THE ON BOARD DILUTION. THE SAME SAMPLE WAS DILUTED MANUALLY AND TESTED ON BOTH ADVIA CENTAUR XP INSTRUMENTS, RESULTING HIGHER. IT IS NOT KNOWN IF THE REPEAT RESULTS WERE REPORTED TO PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE FALSELY LOW CA19-9 RESULTS. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENT DUE TO THE FALSELY LOW CA19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7298040 ↗
• MalfunctionFeb 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW CA19-9 RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULTS WERE OBTAINED WHEN THE SAMPLE WAS DILUTED ON BOARD BY THE INSTRUMENT. ONE OF THE FALSELY LOW RESULTS WAS REPORTED TO PHYSICIAN(S). THE SAME SAMPLE WAS TESTED ON AN ALTERNATE ADVIA CENTAUR XP AND RESULTED HIGHER ON THE ON BOARD DILUTION. THE SAME SAMPLE WAS DILUTED MANUALLY AND TESTED ON BOTH ADVIA CENTAUR XP INSTRUMENTS, RESULTING HIGHER. IT IS NOT KNOWN IF THE REPEAT RESULTS WERE REPORTED TO PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE FALSELY LOW CA19-9 RESULTS. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENT DUE TO THE FALSELY LOW CA19-9 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7298031 ↗
• MalfunctionNov 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SMOKE WAS EMITTED FROM AN ADVIA CENTAUR XP INSTRUMENT. THE INSTRUMENT WAS POWERED OFF AND UNPLUGGED BY THE HOSPITAL FIRE SQUAD. THERE WERE NO INJURIES TO LABORATORY PERSONNEL AND NO PATIENT SAMPLES WERE AFFECTED DUE TO THE SMOKE EMITTED FROM THE SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6997772 ↗
• MalfunctionOct 20, 2017Mechanical Problem; Mechanical Problem

  DURING TROUBLESHOOTING OF AN ADVIA CENTAUR XP INSTRUMENT, THE SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SPLASHED IN THE FACE WITH WASTE FLUID. THE CSE WAS WEARING A GOWN AND GLOVES BUT NOT PROTECTIVE EYE-WARE. THE CSE WENT TO THE EMERGENCY ROOM WHERE INFECTIOUS DISEASE TESTING WAS CARRIED OUT, AND RESULTED NEGATIVE. THE CSE DID NOT RECEIVE TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6964828 ↗
• MalfunctionJul 25, 2017Device Issue; Device Issue

  THE ADVIA CENTAUR XP INSTRUMENT USER INTERFACE PRODUCED A BLACK SCREEN UPON INSTRUMENT BOOT UP. THE CUSTOMER SWITCHED THE INSTRUMENT OFF AND ON SEVERAL TIMES. THE CUSTOMER DID NOT HAVE A BACKUP SYSTEM FOR TESTING, CAUSING DELAY IN TESTING PATIENT SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INSTRUMENT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6742177 ↗

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