ADVIA Centaur® PTH 10699154Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00630414592336), received between Feb 15, 2018 and Oct 17, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY ELEVATED INTACT PARATHYROID HORMONE (PTH) RESULTS ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XPT ANALYZER. ON (B)(6) 2025, THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAME SAMPLE WAS RETESTED TWICE ON THE ORIGINAL ADVIA CENTAUR XPT ANALYZER AND OBTAINED THE ELEVATED RESULTS SAME AS INITIAL RESULT. THE SAMPLE WAS RETESTED ON AN ALTERNATE NON-SIEMENS ANALYZER, AND A LOWER RESULT WAS OBTAINED CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY. THE SAMPLE WAS TREATED WITH HETEROPHILIC ANTIBODY BLOCKING REAGENT AND RETESTED ON AN ALTERNATE NON-SIEMENS ANALYZER AND A LOWER RESULT WAS OBTAINED AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER INVESTIGATED THE SAMPLE FOR HETEROPHILIC ANTIBODIES AND FOUND A HETEROPHILIC ANTIBODY INTERFERENCE. THEN, THE CUSTOMER TREATED THE SAMPLE WITH HETEROPHILIC ANTIBODY BLOCKING REAGENT AND RETESTED WHICH GAVE ACCEPTABLE RESULTS. ON (B)(6) 2025, THE SAME SAMPLE WAS PROCESSED ON THE ORIGINAL ADVIA CENTAUR XPT ANALYZER AND ELEVATED RESULT WAS OBTAINED CONSIDERED ERRONEOUS. THE SAMPLE WAS TREATED WITH HETEROPHILIC ANTIBODY BLOCKING REAGENT AND RETESTED ON THE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322835 ↗
• MalfunctionOct 17, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY ELEVATED INTACT PARATHYROID HORMONE (PTH) RESULTS ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XPT ANALYZER. ON (B)(6) 2025, THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAME SAMPLE WAS RETESTED TWICE ON THE ORIGINAL ADVIA CENTAUR XPT ANALYZER AND OBTAINED THE ELEVATED RESULTS SAME AS INITIAL RESULT. THE SAMPLE WAS RETESTED ON AN ALTERNATE NON-SIEMENS ANALYZER, AND A LOWER RESULT WAS OBTAINED CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY. THE SAMPLE WAS TREATED WITH HETEROPHILIC ANTIBODY BLOCKING REAGENT AND RETESTED ON AN ALTERNATE NON-SIEMENS ANALYZER AND A LOWER RESULT WAS OBTAINED AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER INVESTIGATED THE SAMPLE FOR HETEROPHILIC ANTIBODIES AND FOUND A HETEROPHILIC ANTIBODY INTERFERENCE. THEN, THE CUSTOMER TREATED THE SAMPLE WITH HETEROPHILIC ANTIBODY BLOCKING REAGENT AND RETESTED WHICH GAVE ACCEPTABLE RESULTS. ON (B)(6) 2025, THE SAME SAMPLE WAS PROCESSED ON THE ORIGINAL ADVIA CENTAUR XPT ANALYZER AND ELEVATED RESULT WAS OBTAINED CONSIDERED ERRONEOUS. THE SAMPLE WAS TREATED WITH HETEROPHILIC ANTIBODY BLOCKING REAGENT AND RETESTED ON THE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322815 ↗
• MalfunctionFeb 13, 2023High Test Results; High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ADVIA CENTAUR INTACT PARATHYROID HORMONE (PTH) RESULT FOR ONE PATIENT. THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA CENTAUR INSTRUMENT, AND THE RESULT WAS LOWER. THE REPEAT RESULT WAS CONSIDERED AS THE CORRECT RESULT BY THE PHYSICIAN(S). THE INITIAL RESULT WAS REPORTED TO PHYSICIAN(S), WHO DID NOT QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PTH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363403 ↗
• MalfunctionMay 22, 2019No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) RESULTS WERE OBTAINED FOR A "BIG AMOUNT" OF PATIENT SAMPLES. THE RESULTS WERE HIGHER THAN EXPECTED. THE SAMPLES WERE REPEATED, AND THE RESULTS WERE LOWER. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8632787 ↗
• MalfunctionMay 22, 2019No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) RESULTS WERE OBTAINED FOR A "BIG AMOUNT" OF PATIENT SAMPLES. THE RESULTS WERE HIGHER THAN EXPECTED. THE SAMPLES WERE REPEATED, AND THE RESULTS WERE LOWER. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8632776 ↗
• MalfunctionApr 26, 2019No Apparent Adverse Event; No Apparent Adverse Event

  AN ELEVATED RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON THE ADVIA CENTAUR CP INTACT PARATHYROID HORMONE (PTH) ASSAY. THE PTH INTEROPERATIVE ELEVATED RESULT WAS QUESTIONED BY THE PHYSICIAN DUE TO RESULT NOT MATCHING PATIENT HISTORY. THE HISTORICAL PTH LEVELS WERE AROUND 100 PG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS LOWER. THE RESULTS FOR THE CONSECUTIVE DRAWS WERE LOWER. THE SUBSEQUENT DRAWS SHOWED A DECREASE IN INTACT PARATHYROID HORMONE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8554687 ↗
• MalfunctionApr 26, 2019No Apparent Adverse Event; No Apparent Adverse Event

  AN ELEVATED RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON THE ADVIA CENTAUR CP INTACT PARATHYROID HORMONE (PTH) ASSAY. THE PTH INTEROPERATIVE ELEVATED RESULT WAS QUESTIONED BY THE PHYSICIAN DUE TO RESULT NOT MATCHING PATIENT HISTORY. THE HISTORICAL PTH LEVELS WERE AROUND 100 PG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS LOWER. THE RESULTS FOR THE CONSECUTIVE DRAWS WERE LOWER. THE SUBSEQUENT DRAWS SHOWED A DECREASE IN INTACT PARATHYROID HORMONE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8554686 ↗
• MalfunctionJan 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT ELEVATED RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON THE ADVIA CENTAUR CP INTACT PARATHYROID HORMONE (PTH) ASSAY. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE RESULT WAS HIGHER THAN EXPECTED. THE SAMPLE WAS REPEATED AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. THE SAME PATIENT HAD A SAMPLE DRAWN ON DECEMBER 22ND. THE SAMPLE WAS TESTED AND THE RESULT WAS ELEVATED. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE RESULT WAS HIGHER THAN EXPECTED. THE SAMPLE WAS REPEATED AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8238396 ↗
• MalfunctionJan 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON THE ADVIA CENTAUR CP INTACT PARATHYROID HORMONE (PTH) ASSAY. THE INITIAL ELEVATED RESULT WAS QUESTIONED BY THE CUSTOMER AND REPEATED. THE REPEAT RESULT WAS LOWER. THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN HAS NOT QUESTIONED THE RESULT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8238313 ↗
• MalfunctionJan 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT ELEVATED RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON THE ADVIA CENTAUR CP INTACT PARATHYROID HORMONE (PTH) ASSAY. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE RESULT WAS HIGHER THAN EXPECTED. THE SAMPLE WAS REPEATED AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. THE SAME PATIENT HAD A SAMPLE DRAWN ON (B)(6). THE SAMPLE WAS TESTED AND THE RESULT WAS ELEVATED. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE RESULT WAS HIGHER THAN EXPECTED. THE SAMPLE WAS REPEATED AND THE RESULT WAS LOWER. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8238303 ↗
• MalfunctionDec 27, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED AN ADVIA CENTAUR XP INTACT PTH RESULT OF 484 PG/ML THAT WAS ELEVATED COMPARED TO AN ALTERNATE METHOD AND THE CLINICAL PICTURE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED ON ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP INTACT PTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8201039 ↗
• MalfunctionSep 18, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSELY HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULT WAS OBTAINED ON A PATIENT SAMPLE (FIRST), AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN AS IT DID NOT REPRESENT THE CLINICAL PICTURE OF THE PATIENT. THE PATIENT WAS DRAWN A SECOND TIME, AND THE IPTH RESULT RUN ON THE SAME REAGENT READYPACK WAS LOWER. A CORRECTED REPORT WAS ISSUED BY THE CUSTOMER. THE PATIENT SAMPLES WERE SENT TO AN ALTERNATE LABORATORY, AND THE RESULTS OBTAINED WERE SIMILAR. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP IPTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7887423 ↗
• MalfunctionApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT ELEVATED RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON THE ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAY. THE RESULT WAS QUESTIONED BY THE PHYCISIAN. THE RESULT WAS HIGHER THAN EXPECTED, THE SAMPLE WAS REPEATED THREE TIMES ON A LATER DATE AND THE RESULTS WERE ELEVATED. A REDRAW PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AT A DIFFERENT LOCATION AND THE RESULT WAS LOWER. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7432975 ↗
• MalfunctionApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT ELEVATED RESULT WAS OBTAINED FOR A PATIENT SAMPLE ON THE ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAY. THE RESULT WAS QUESTIONED BY THE PHYCISIAN. THE RESULT WAS HIGHER THAN EXPECTED, THE SAMPLE WAS REPEATED THREE TIMES ON A LATER DATE AND THE RESULTS WERE ELEVATED. A REDRAW PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AT A DIFFERENT LOCATION AND THE RESULT WAS LOWER. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7432973 ↗
• MalfunctionFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSELY ELEVATED ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) RESULT COMPARED TO HISTORICAL RESULTS WAS OBSERVED. THE PHYSICIAN QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP PTH RESULT. MDR 1219913-2018-00079 WAS FILED FOR A SAMPLE FROM THE SAME PATIENT TESTED IN (B)(6) 2017 AND MDR 1219913-2018-00081 WAS FILED FOR A SAMPLE FROM THE SAME PATIENT TESTED IN (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7274760 ↗
• MalfunctionFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSELY ELEVATED ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) RESULT COMPARED TO HISTORICAL RESULTS WAS OBSERVED. THE PHYSICIAN QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP PTH RESULT. MDR 1219913-2018-00080 WAS FILED FOR A SAMPLE FROM THE SAME PATIENT TESTED IN (B)(6) 2017 AND MDR 1219913-2018-00081 WAS FILED FOR A SAMPLE FROM THE SAME PATIENT TESTED IN (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7274758 ↗
• MalfunctionFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSELY ELEVATED ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) RESULT COMPARED TO HISTORICAL RESULTS WAS OBSERVED. THE PHYSICIAN QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP PTH RESULT. MDR 1219913-2018-00079 WAS FILED FOR A SAMPLE FROM THE SAME PATIENT TESTED IN (B)(6) 2017 AND MDR 1219913-2018-00080 WAS FILED FOR A SAMPLE FROM THE SAME PATIENT TESTED IN (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7274757 ↗