ADVIA Centaur® TnI-Ultra™ 10317709Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00630414516226), received between Oct 23, 2017 and Dec 30, 2021 — classified as 36 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 reports).

4 other recalls cover devices cleared under the same FDA submission (K053020); 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR XP TROPONIN-I ULTRA (TNI-ULTRA) RESULTS FOR FIVE PATIENT SAMPLES THAT WERE DISCORDANT COMPARED TO REPEAT TESTING ON A FRESHLY OPENED REAGENT PACK. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP TNI-ULTRA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119494 ↗
• MalfunctionJul 13, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP TNI-ULTRA RESULTS WERE OBTAINED ON FIVE PATIENTS. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER OBSERVED THAT THERE WERE NO REMAINING TESTS AVAILABLE TO PERFORM REPEAT TESTING WITH THE SAME REAGENT READYPACK. THE SAME PATIENT SAMPLES WERE REPEATED WITH A NEW REAGENT READYPACK FROM THE SAME REAGENT LOT, ALL RESULTING LOWER. THE LOWER RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP TNI-ULTRA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160841 ↗
• MalfunctionMar 19, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR TNI-ULTRA ASSAY RESULT WAS OBTAINED ON A PATIENT SAMPLE AND QUESTIONED BY THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAME SAMPLE AFTER CENTRIFUGATION, RESULTING HIGH. THE SAME SAMPLE WAS TESTED ON TWO ALTERNATE TROPONIN TEST METHODS, RESULTING LOWER. THE LOWER RESULT AGREED WITH WHAT WAS EXPECTED. THE LOWER RESULT WAS REPORTED TO THE PHYSICIAN(S) AS A CORRECTED RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR TNI-ULTRA ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529919 ↗
• MalfunctionOct 1, 2020High Test Results; High Test Results

  ON (B)(6) 2020, A DISCORDANT, FALSELY-ELEVATED ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA) RESULT WAS OBSERVED FOR ONE PATIENT SAMPLE. THE SAME SAMPLE WAS RE-TESTED TWICE ON THE SAME SYSTEM. PRODUCING REPRODUCIBLY LOWER RESULTS. THE REPEAT TNI-ULTRA RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY-ELEVATED ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10613340 ↗
• MalfunctionAug 21, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA) INITIAL RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES. THE CUSTOMER PERFORMED REPEAT TNI-ULTRA TESTING ON THE SAME SAMPLES WITH A NEW REAGENT READYPACK FROM THE SAME REAGENT LOT NUMBER, RESULTING LOWER. THE REPEAT TNI-ULTRA RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10438024 ↗
• MalfunctionDec 23, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED ADVIA CENTAUR XP TNI ULTRA RESULTS ON (B)(6) 2019 ON ONE INSTRUMENT WITH ONE REAGENT READYPACK. QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER RANGE ON (B)(6) 2019 PRIOR TO RUNNING PATIENT SAMPLES. QC WAS HIGH OUT OF THE CUSTOMER RANGE THE NEXT MORNING (B)(6) 2019 AFTER PATIENT SAMPLES WERE RUN. THIS ALERTED THE CUSTOMER OF THE ISSUE AND THE PATIENT SAMPLES WERE REPEATED. THE REPEATED RESULTS WERE ALL LOWER THAN THE INITIAL RESULTS. CORRECTED REPORTS WERE ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INITIAL ELEVATED TNI ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9513082 ↗
• MalfunctionDec 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS POSITIVE. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS TREATED WITH PEG (POLYETHYLENE GLYCOL 6000) AND THE RESULT WAS LOWER. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE RESULT WAS ACCEPTED BY THE PHYSICIAN AS IT MATCHED THE CLINICAL PICTURE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9467881 ↗
• MalfunctionDec 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS POSITIVE. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS TREATED WITH PEG (POLYETHYLENE GLYCOL 6000) AND THE RESULT WAS LOWER. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE RESULT WAS ACCEPTED BY THE PHYSICIAN AS IT MATCHED THE CLINICAL PICTURE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9467865 ↗
• MalfunctionJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT HIGH ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULTS WERE OBTAINED FOR SAMPLES FROM FIVE PATIENTS DURING A LOT TO LOT CORRELATION. THE CORRELATION WAS BETWEEN TNI-ULTRA LOT 149 AND LOT 160. THE RESULTS WERE HIGHER WITH LOT 160. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8740919 ↗
• MalfunctionJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSELY ELEVATED ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS TESTED ON THE ALTERNATE SYSTEM AND THE RESULT WAS NEGATIVE. A NEW SAMPLE WAS TESTED, AND THE RESULT WAS NEGATIVE. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8698141 ↗
• MalfunctionMar 27, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A FALSELY ELEVATED ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON THE OTHER ADVIA CENTAUR CP AND THE RESULT WAS NEGATIVE. A NEW SAMPLE WAS TESTED, AND THE RESULT WAS NEGATIVE. THE NEW SAMPLE CONFIRMED THE NEGATIVE RESULT. THE NEGATIVE RESULT WAS REPORTED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8456930 ↗
• MalfunctionMar 21, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON (B)(6) 2019. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS POSITIVE. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PHYSICIAN SENT THE PATIENT TO (B)(6) HOSPITAL WHERE ANOTHER SAMPLE WAS OBTAINED AND TESTED FOR TROPONIN ON AN ALTERNATE METHOD. THE RESULT WAS NEGATIVE. THE PATIENT HAD A SAMPLE COLLECTED ON (B)(6) 2019 AND TESTED ON THE ADVIA CENTAUR XP FOR TNI-ULTRA. THE RESULT WAS POSITIVE. THE SAMPLE WAS REPEATED AND THE RESULT WAS POSITIVE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAMPLE WAS SENT INTERNALLY TO A BRANCH LABORATORY FOR ANALYSIS ON THE SIEMENS DIMENSION EXL AND THE RESULT WAS NEGATIVE. A CORRECTED REPORT WAS ISSUED. THE PATIENT DID NOT HAVE ANY CLINICAL FEATURES OF A CARDIAC EVENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8441530 ↗
• MalfunctionMar 21, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON (B)(6) 2019. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS POSITIVE. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PHYSICIAN SENT THE PATIENT TO (B)(6) HOSPITAL WHERE ANOTHER SAMPLE WAS OBTAINED AND TESTED FOR TROPONIN ON AN ALTERNATE METHOD. THE RESULT WAS NEGATIVE. THE PATIENT HAD A SAMPLE COLLECTED ON (B)(6) 2019 AND TESTED ON THE ADVIA CENTAUR XP FOR TNI-ULTRA. THE RESULT WAS POSITIVE. THE SAMPLE WAS REPEATED AND THE RESULT WAS POSITIVE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAMPLE WAS SENT INTERNALLY TO A BRANCH LABORATORY FOR ANALYSIS ON THE SIEMENS DIMENSION EXL AND THE RESULT WAS NEGATIVE. A CORRECTED REPORT WAS ISSUED. THE PATIENT DID NOT HAVE ANY CLINICAL FEATURES OF A CARDIAC EVENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8441528 ↗
• MalfunctionFeb 25, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR CP TROPONIN ULTRA - (TNI-ULTRA) RESULT THAT WAS LOWER UPON REPEAT TESTING. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR CP TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8367826 ↗
• MalfunctionNov 14, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A FALSELY ELEVATED ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED AGAIN AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS TESTED ON THE OTHER ADVIA CENTAUR CP AND THE RESULT WAS NEGATIVE. THE NEGATIVE RESULT WAS REPORTED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8069141 ↗
• MalfunctionOct 22, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A (B)(6) ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS INITIALLY TESTED ON THE OTHER ADVIA CENTAUR CP AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS REPEATED ON THE OTHER ADVIA CENTAUR CP AND THE RESULT WAS POSITIVE. THE POSITIVE RESULT WAS REPORTED OUT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7990747 ↗
• MalfunctionOct 9, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSELY ELEVATED ADVIA CENTAUR CP CARDIAC TROPONIN I (TNI-ULTRA) RESULT WAS OBSERVED ON THE EVENING SHIFT BY LABORATORY SUPERVISOR WHEN REVIEWING TROPONIN PATIENT RESULTS. THE SECOND DRAWN TNI-ULTRA RESULT FOR THIS PATIENT WAS NORMAL. THE CUSTOMER PERFORMED REPEAT TNI-ULTRA TESTING ON AN ALTERNATE ADVIA CENTAUR CP SYSTEM OF THE FIRST SAMPLE, AND THE RESULTS WERE NORMAL. A CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR CP TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7949625 ↗
• MalfunctionSep 18, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. AFTER FOUR HOURS, A SECOND SAMPLE FROM THE SAME PATIENT WAS TESTED AND THE RESULT WAS NEGATIVE. BOTH SAMPLES WERE REPEATED AND THE RESULTS WERE NEGATIVE. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7885008 ↗
• MalfunctionAug 16, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE LABORATORY RECEIVED TWO SAMPLES FROM THE SAME PATIENT DRAWN 1 MINUTE APART. BOTH SAMPLE WERE RUN UNDER DIFFERENT SID'S FOR TROPONIN. ONE RESULT WAS HIGH AND THE OTHER WAS NEGATIVE. BOTH RESULTS WERE REPORTED TO THE DOCTOR. THE DOCTOR QUESTIONED THE RESULTS. THE LABORATORY REPEATED BOTH SAMPLES ON THE ADVIA CENTAUR XP AND THE RESULTS WERE NEGATIVE. BOTH SAMPLES WERE THEN RUN ON THE ADVIA CENTAUR CP AND BOTH RESULTS WERE NEGATIVE. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7788587 ↗
• MalfunctionAug 3, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A FALSELY ELEVATED ADVIA CENTAUR CP CARDIAC TROPONIN I (TNI-ULTRA) INITIAL RESULT WAS OBSERVED BY THE CUSTOMER, AND CONSIDERED DISCORDANT WHEN COMPARED TO FOLLOW UP TNI-ULTRA TEST RESULTS. THE INITIALLY ELEVATED TNI-ULTRA RESULT WAS REPORTED TO THE LABORATORY PHYSICIAN WHO ORDERED A NEW SAMPLE BLOOD DRAW, AND THE RESULT WAS LOWER. ANOTHER SAMPLE DRAW WAS ORDERED, AND THE TNI-ULTRA RESULT WAS LOWER. THE CUSTOMER PERFORMED REPEAT TESTING ON THE ORIGINAL SAMPLE, AND THE RESULT WAS LOWER. THE INITIALLY ELEVATED TNI-ULTRA RESULT WAS NOT REPORTED TO THE PROVIDER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR CP TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7749023 ↗
• MalfunctionJun 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER OBSERVED FALSELY LOW ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) PATIENT RESULTS WHEN PERFORMING A COMPARISON OF REAGENT LOT (010128) TO A NEWER REAGENT LOT (010132) RECEIVED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR XP TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7582314 ↗
• MalfunctionJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE HIGH ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE PATIENT SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND THE OTHER ADVIA CENTAUR CP. THE RESULTS WERE LOWER. THE LOWER RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7577840 ↗
• MalfunctionJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE HIGH ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE PATIENT SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND THE OTHER ADVIA CENTAUR CP. THE RESULTS WERE NEGATIVE. THE NEGATIVE RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7577831 ↗
• MalfunctionJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSELY ELEVATED ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS REPORTED FOR THE IN-PATIENT AND QUESTIONED BY THE PHYSICIAN. THE PATIENT SAMPLE WAS REPEATED WITHOUT RESPINNING AND THE RESULT WAS NEGATIVE. A CORRECTED REPORT WAS ISSUED. THE LEAD TECHNICIAN REPEATED THE SAME SAMPLE TUBE IN THE MORNING, WITHOUT RESPINNING THE TUBE, AND THE RESULT WAS NEGATIVE. THE CORRECTED RESULT MATCHED THE PATIENT'S CLINICAL SYMPTOMS. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7577824 ↗
• MalfunctionMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE HIGH ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED ON THE OTHER ADVIA CENTAUR CP AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS THEN REPEATED ON BOTH INSTRUMENTS AND THE RESULTS WERE NEGATIVE. NO PHYSICIAN QUESTIONED THE RESULT AND NO CORRECTED REPORT WAS ISSUED. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7514329 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053020. One submission often covers many models, so check the product and lot details in each record.

• Z-2041-2016 · May 2, 2016 · Terminated
  Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determina
• Z-2207-2015 · May 19, 2015 · Terminated
  ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponi
• Z-1991-2014 · May 30, 2014 · Terminated
  ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
• Z-0580-2008 · Jun 7, 2007 · Terminated
  ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solu