ADVIA Centaur® TnI-Ultra™ 10317708Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00630414516219), received between Jun 29, 2017 and Nov 10, 2020 — classified as 45 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2020High Test Results; High Test Results

  A DISCORDANT HIGH RESULT WAS OBSERVED FOR ONE PATIENT WHEN USING THE ADVIA CENTAUR XP TROPONIN I ULTRA (TNI-ULTRA) ASSAY. THE INITIAL RESULT WAS POSITIVE; REPEAT TESTING USING THE SAME INSTRUMENT, ASSAY, AND REAGENT PACK PRODUCED A NEGATIVE RESULT. ADDITIONAL TESTING USING THE BECKMAN COULTER UNICEL DXI 800 SYSTEM ALSO PRODUCED A NEGATIVE RESULT. 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 10817808 ↗
• MalfunctionJun 5, 2020High Test Results; High Test Results

  A CUSTOMER OBSERVED A DISCORDANT HIGH RESULT FOR TWO DIFFERENT PATIENTS USING ADVIA CENTAUR CP TNI ULTRA. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE EMERGENCY ROOM PHYSICIAN(S). THE LABORATORY TECHNICIAN(S) RETESTED THE SAMPLE AND NEGATIVE RESULTS (<0.02 NG/ML) WERE OBSERVED, AS EXPECTED. THE RETEST RESULTS WERE REPORTED TO THE PHYSICIAN(S). TWO ADDITIONAL DRAWS WERE TAKEN FROM EACH PATIENT AND NEGATIVE RESULTS WERE AGAIN OBSERVED. SAMPLE DRAW TIMES WERE NOT PROVIDED. SST TIGER TOP SAMPLE TUBES WERE USED FOR SAMPLE COLLECTION. QUALITY CONTROL WAS IN RANGE. THE SAME INSTRUMENT WAS USED TO TEST ALL SAMPLES. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED BASED ON THE TNI ULTRA RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10125450 ↗
• MalfunctionJun 5, 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 CUSTOMER OBTAINED DISCORDANT LOW RESULTS (NEGATIVE) FOR ONE PATIENT ((B)(6) WITH THE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY VERSUS ALTERNATE METHODS. THE INITIAL ADVIA CENTAUR CP TNI-ULTRA RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIAN. QUALITY CONTROL RESULTS WERE IN RANGE. A SECOND ALIQUOT FROM THE SAME PATIENT WAS TESTED WITH ADVIA CENTAUR CP TNIULTRA, ADVIA CENTAUR XP TNI-ULTRA AND (3) ALTERNATE METHODS. THE CUSTOMER BELIEVES THAT THE ADVIA CENTAUR SYSTEMS TNIULTRA LOW RESULTS TO BE DISCORDANT AND THE ALTERNATE METHOD RESULTS TO BE CORRECT. A CORRECTED REPORT WAS RELEASED. IN ADDITION, ADDITIONAL PATIENT SAMPLE ((B)(6)) WAS TESTED FOR COMPARISON ONLY BETWEEN ADVIA CENTAUR CP TNI ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND ALTERNATE METHODS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672674 ↗
• MalfunctionJun 5, 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 CUSTOMER OBTAINED DISCORDANT LOW RESULTS (NEGATIVE) FOR ONE PATIENT (SID (B)(6)) WITH THE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY VERSUS ALTERNATE METHODS. THE INITIAL ADVIA CENTAUR CP TNI-ULTRA RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIAN. QUALITY CONTROL RESULTS WERE IN RANGE. A SECOND ALIQUOT FROM THE SAME PATIENT WAS TESTED WITH ADVIA CENTAUR CP TNIULTRA, ADVIA CENTAUR XP TNI-ULTRA AND (3) ALTERNATE METHODS. THE CUSTOMER BELIEVES THAT THE ADVIA CENTAUR SYSTEMS TNI-ULTRA LOW RESULTS TO BE DISCORDANT AND THE ALTERNATE METHOD RESULTS TO BE CORRECT. A CORRECTED REPORT WAS RELEASED. IN ADDITION, ADDITIONAL PATIENT SAMPLE (SID (B)(6)) WAS TESTED FOR COMPARISON ONLY BETWEEN ADVIA CENTAUR CP TNI ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND ALTERNATE METHODS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672673 ↗
• MalfunctionJun 5, 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 CUSTOMER OBTAINED DISCORDANT LOW RESULTS (NEGATIVE) FOR ONE PATIENT ((B)(6)) WITH THE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY VERSUS ALTERNATE METHODS. THE INITIAL ADVIA CENTAUR CP TNI-ULTRA RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIAN. QUALITY CONTROL RESULTS WERE IN RANGE. A SECOND ALIQUOT FROM THE SAME PATIENT WAS TESTED WITH ADVIA CENTAUR CP TNIULTRA, ADVIA CENTAUR XP TNI-ULTRA AND (3) ALTERNATE METHODS. THE CUSTOMER BELIEVES THAT THE ADVIA CENTAUR SYSTEMS TNIULTRA LOW RESULTS TO BE DISCORDANT AND THE ALTERNATE METHOD RESULTS TO BE CORRECT. A CORRECTED REPORT WAS RELEASED. IN ADDITION, ADDITIONAL PATIENT SAMPLE ((B)(6)) WAS TESTED FOR COMPARISON ONLY BETWEEN ADVIA CENTAUR CP TNI ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND ALTERNATE METHODS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672672 ↗
• MalfunctionJun 5, 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 CUSTOMER OBTAINED DISCORDANT LOW RESULTS (NEGATIVE) FOR ONE PATIENT ((B)(6)) WITH THE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY VERSUS ALTERNATE METHODS. THE INITIAL ADVIA CENTAUR CP TNI-ULTRA RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIAN. QUALITY CONTROL RESULTS WERE IN RANGE. A SECOND ALIQUOT FROM THE SAME PATIENT WAS TESTED WITH ADVIA CENTAUR CP TNIULTRA, ADVIA CENTAUR XP TNI-ULTRA AND (3) ALTERNATE METHODS. THE CUSTOMER BELIEVES THAT THE ADVIA CENTAUR SYSTEMS TNI-ULTRA LOW RESULTS TO BE DISCORDANT AND THE ALTERNATE METHOD RESULTS TO BE CORRECT. A CORRECTED REPORT WAS RELEASED. IN ADDITION, ADDITIONAL PATIENT SAMPLE ((B)(6)) WAS TESTED FOR COMPARISON ONLY BETWEEN ADVIA CENTAUR CP TNI ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND ALTERNATE METHODS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672670 ↗
• MalfunctionJun 5, 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 CUSTOMER OBTAINED DISCORDANT LOW RESULTS (NEGATIVE) FOR ONE PATIENT (SID (B)(6)) WITH THE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY VERSUS ALTERNATE METHODS. THE INITIAL ADVIA CENTAUR CP TNI-ULTRA RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIAN. QUALITY CONTROL RESULTS WERE IN RANGE. A SECOND ALIQUOT FROM THE SAME PATIENT WAS TESTED WITH ADVIA CENTAUR CP TNI ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND (3) ALTERNATE METHODS. THE CUSTOMER BELIEVES THAT THE ADVIA CENTAUR SYSTEMS TNI-ULTRA LOW RESULTS TO BE DISCORDANT AND THE ALTERNATE METHOD RESULTS TO BE CORRECT. A CORRECTED REPORT WAS RELEASED. IN ADDITION, ADDITIONAL PATIENT SAMPLE (SID (B)(6)) WAS TESTED FOR COMPARISON ONLY BETWEEN ADVIA CENTAUR CP TNI ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND ALTERNATE METHODS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672669 ↗
• MalfunctionJun 5, 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 CUSTOMER OBTAINED DISCORDANT LOW RESULTS (NEGATIVE) FOR ONE PATIENT ((B)(6)) WITH THE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY VERSUS ALTERNATE METHODS. THE INITIAL ADVIA CENTAUR CP TNI-ULTRA RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIAN. QUALITY CONTROL RESULTS WERE IN RANGE. A SECOND ALIQUOT FROM THE SAME PATIENT WAS TESTED WITH ADVIA CENTAUR CP TNI-ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND (3) ALTERNATE METHODS. THE CUSTOMER BELIEVES THAT THE ADVIA CENTAUR SYSTEMS TNI-ULTRA LOW RESULTS TO BE DISCORDANT AND THE ALTERNATE METHOD RESULTS TO BE CORRECT. A CORRECTED REPORT WAS RELEASED. IN ADDITION, ADDITIONAL PATIENT SAMPLE ((B)(6)) WAS TESTED FOR COMPARISON ONLY BETWEEN ADVIA CENTAUR CP TNI ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND ALTERNATE METHODS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672668 ↗
• MalfunctionJun 5, 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 CUSTOMER OBTAINED DISCORDANT LOW RESULTS (NEGATIVE) FOR ONE PATIENT (SID (B)(6)) WITH THE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) ASSAY VERSUS ALTERNATE METHODS. THE INITIAL ADVIA CENTAUR CP TNI-ULTRA RESULTS WERE REPORTED AND QUESTIONED BY PHYSICIAN. QUALITY CONTROL RESULTS WERE IN RANGE. A SECOND ALIQUOT FROM THE SAME PATIENT WAS TESTED WITH ADVIA CENTAUR CP TNIULTRA, ADVIA CENTAUR XP TNI-ULTRA AND (3) ALTERNATE METHODS. THE CUSTOMER BELIEVES THAT THE ADVIA CENTAUR SYSTEMS TNI-ULTRA LOW RESULTS TO BE DISCORDANT AND THE ALTERNATE METHOD RESULTS TO BE CORRECT. A CORRECTED REPORT WAS RELEASED. IN ADDITION, ADDITIONAL PATIENT SAMPLE (SID (B)(6)) WAS TESTED FOR COMPARISON ONLY BETWEEN ADVIA CENTAUR CP TNI ULTRA, ADVIA CENTAUR XP TNI-ULTRA AND ALTERNATE METHODS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672667 ↗
• MalfunctionApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSELY ELEVATED ADVIA CENTAUR XPT TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 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 8565073 ↗
• MalfunctionOct 1, 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 PATIENT WAS IN THE EMERGENCY ROOM (ER). THE LABORATORY PROTOCOL IS TO REPEAT ANY SAMPLE THAT IS >0.09. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS LOWER THAN 0.09. THE PATIENT SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS LOWER THAN 0.09. THE THIRD RESULT WAS REPORTED TO THE ER PHYSICIAN. THE ER PHYSICIAN DID NOT QUESTION THE RESULT. 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 7923529 ↗
• MalfunctionOct 1, 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 PATIENT WAS IN THE EMERGENCY ROOM (ER). THE LABORATORY PROTOCOL IS TO REPEAT ANY SAMPLE THAT IS >0.09. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS LOWER THAN 0.09. THE PATIENT SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS LOWER THAN 0.09. THE THIRD RESULT WAS REPORTED TO THE ER PHYSICIAN. THE ER PHYSICIAN DID NOT QUESTION THE RESULT. 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 7923524 ↗
• MalfunctionSep 7, 2018No Apparent Adverse Event; No Apparent Adverse Event

  ELEVATED ADVIA CENTAUR CP CARDIAC TROPONIN I (TNI-ULTRA) RESULTS WERE OBSERVED BY THE CUSTOMER ON AN INITIAL SAMPLE TUBE DRAW, AND SERIAL SAMPLE TUBE DRAW. THE ADVIA CENTAUR CP IS USED AS A BACK-UP SYSTEM, AND THE ELEVATED ADVIA CENTAUR CP RESULTS WERE CONSIDERED BY THE CUSTOMER TO BE DISCORDANT COMPARED TO THEIR PRIMARY INSTRUMENT (DIMENSION EXL) AND TROPONIN TEST METHOD. THE RESULTS FROM THE PRIMARY INSTRUMENT (DIMENSION EXL) AND TROPONIN TEST METHOD WERE REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR CP TNI-ULTRA RESULTS. MDR 1219913-2018-00223 WAS FILED FOR THE ELEVATED TROPONIN RESULT ON THE INITIAL SAMPLE TUBE (PT1A).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7857501 ↗
• MalfunctionSep 7, 2018No Apparent Adverse Event; No Apparent Adverse Event

  ELEVATED ADVIA CENTAUR CP CARDIAC TROPONIN I (TNI-ULTRA) RESULTS WERE OBSERVED BY THE CUSTOMER ON AN INITIAL SAMPLE TUBE DRAW, AND SERIAL SAMPLE TUBE DRAW. THE ADVIA CENTAUR CP IS USED AS A BACK-UP SYSTEM, AND THE ELEVATED ADVIA CENTAUR CP RESULTS WERE CONSIDERED BY THE CUSTOMER TO BE DISCORDANT COMPARED TO THEIR PRIMARY INSTRUMENT (DIMENSION EXL) AND TROPONIN TEST METHOD. THE RESULTS FROM THE PRIMARY INSTRUMENT (DIMENSION EXL) AND TROPONIN TEST METHOD WERE REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR CP TNI-ULTRA RESULTS. MDR 1219913-2018-00224 WAS FILED FOR THE ELEVATED TROPONIN RESULT ON THE SERIAL SAMPLE TUBE ((B)(6)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7857499 ↗
• MalfunctionJul 9, 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 PATIENT SAMPLE WAS REPEATED ON A SECOND ADVIA CENTAUR XP AND THE RESULT WAS NEGATIVE. A SECOND SAMPLE FOR THE SAME PATIENT WAS TESTED ON BOTH ADVIA CENTAUR XP SYSTEMS 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 7671576 ↗
• MalfunctionJun 8, 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 ELEVATED. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. THE NEGATIVE RESULTS WERE IN AGREEMENT TO 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 7582278 ↗
• MalfunctionJun 8, 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 ELEVATED. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. THE NEGATIVE RESULTS WERE IN AGREEMENT TO 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 7582277 ↗
• MalfunctionMay 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

  THE CUSTOMER OBSERVED FALSELY ELEVATED ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) PATIENT RESULT WHEN PERFORMING A COMPARISON OF REAGENT LOT (010125) TO REAGENT LOT (010127) RECEIVED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7484462 ↗
• MalfunctionApr 24, 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 PATIENT WAS SENT TO THE HOSPITAL. THE PATIENT WAS TESTED ON AN ALTERNATE METHOD FOR TROPONIN T AT THE HOSPITAL AND THE RESULT WAS NEGATIVE. THE RESULTS WERE QUESTIONED BY THE PHYSICIAN. 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 7455045 ↗
• MalfunctionApr 24, 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 PATIENT WAS SENT TO THE HOSPITAL. THE PATIENT WAS TESTED ON AN ALTERNATE METHOD FOR TROPONIN T AT THE HOSPITAL AND THE RESULT WAS NEGATIVE. A REDRAW SAMPLE WAS TESTED ON THE ALTERNATE METHOD AND THE RESULT WAS NEGATIVE. THE RESULTS WERE QUESTIONED BY THE PHYSICIAN. 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 7455044 ↗
• MalfunctionApr 6, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER OBSERVED FALSELY ELEVATED ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) PATIENT RESULTS WHEN PERFORMING A CORRELATION RUN OF REAGENT LOT (010125) TO REAGENT LOT (010127) RECEIVED. THE CUSTOMER IS USING A NEW REAGENT LOT (010128) FOR REPORTING PATIENT RESULTS. 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 Known Impact Or Consequence To Patient

  MAUDE report 7404336 ↗
• MalfunctionApr 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

  THE CUSTOMER OBSERVED DISCORDANT ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) PATIENT RESULTS WHEN PERFORMING A CORRELATION RUN OF REAGENT LOT (010125) TO NEWER REAGENT LOTS (010127) AND (010128) RECEIVED. THE CUSTOMER HAS DECIDED NOT TO IMPLEMENT REAGENT (010127) FOR GENERAL USE, HOWEVER REAGENT LOT 010128 MEETS THE CUSTOMER'S QUALITY CONTROL (QC) RANGES AND IS NOW IN USE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TNI-ULTRA CORRELATION RESULT WITH REAGENT LOT 010128. MDR 1219913-2018-00124 WAS FILED FOR A DISCORDANT CORRELATION RESULT WITH REAGENT LOT 010127.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7394319 ↗
• MalfunctionApr 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

  THE CUSTOMER OBSERVED DISCORDANT ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) PATIENT RESULTS WHEN PERFORMING A CORRELATION RUN OF REAGENT LOT (010125) TO NEWER REAGENT LOTS (010127) AND (010128) RECEIVED. THE CUSTOMER HAS DECIDED NOT TO IMPLEMENT REAGENT (010127) FOR GENERAL USE, HOWEVER REAGENT LOT 010128 MEETS THE CUSTOMER'S QUALITY CONTROL (QC) RANGES AND IS NOW IN USE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TNI-ULTRA CORRELATION RESULT WITH REAGENT LOT 010127. MDR 1219913-2018-00125 WAS FILED FOR A DISCORDANT CORRELATION RESULT WITH REAGENT LOT 010128.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7394315 ↗
• MalfunctionMar 22, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  DISCORDANT ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULTS WERE OBTAINED ON SAMPLES FROM DIFFERENT PATIENTS DURING A LOT TO LOT CORRELATION. THE CORRELATION WAS BETWEEN REAGENT LOT 127 AND 124. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA (TNI-ULTRA) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7361270 ↗
• MalfunctionMar 6, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  DISCORDANT ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULTS WERE OBTAINED ON SAMPLES FROM EIGHT PATIENTS DURING A LOT TO LOT CORRELATION. THE CORRELATION WAS BETWEEN REAGENT LOT 127 AND 124. THE RESULTS WERE HIGHER WITH LOT 127. THE PATIENT RESULTS FROM LOT 127 WERE NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA (TNI-ULTRA) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7318745 ↗

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