ADVIA Centaur® PTH 10699155Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00630414592343), received between Jun 5, 2018 and Feb 20, 2020 — classified as 7 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT LOW ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PHYSICIAN WAS EXPECTING A HIGHER RESULT. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE HIGHER. 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 9735188 ↗
• MalfunctionMar 15, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE SAMPLE WAS REPEATED AND THE RESULT WAS HIGH. A SECOND SAMPLE FROM THE SAME PATIENT WAS TESTED AND THE RESULT WAS LOWER. THE SECOND SAMPLE WAS REPEATED AND THE RESULT WAS LOWER. RESULTS FROM BOTH SAMPLES WERE REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULTS. 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 8424429 ↗
• MalfunctionMar 15, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE SAMPLE WAS REPEATED AND THE RESULT WAS HIGH. A SECOND SAMPLE FROM THE SAME PATIENT WAS TESTED AND THE RESULT WAS LOWER. THE SECOND SAMPLE WAS REPEATED AND THE RESULT WAS LOWER. RESULTS FROM BOTH SAMPLES WERE REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULTS. 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 8424423 ↗
• MalfunctionOct 5, 2018No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT RESULTS WERE OBTAINED FOR A PATIENT BETWEEN SERUM AND PLASMA SAMPLES ON THE ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (PTH) ASSAY DURING A CORRELATION STUDY BETWEEN LABORATORIES. THE SERUM SAMPLE RESULT WAS LOWER THAN THE PLASMA RESULT. A PHYSICIAN NOTICED THE DIFFERENCE IN RESULTS DURING THE STUDY. 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 7938022 ↗
• MalfunctionJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FALSELY HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULTS WERE OBTAINED ON A PATIENT SAMPLE AND THE RESULTS WERE QUESTIONED BY THE PHYSICIAN. THE PATIENT HAD ELEVATED IPTH RESULTS ON DIFFERENT DAYS FROM THE SAME PATIENT. THE PHYSICIAN WAS EXPECTING A LOWER PTH RESULT, THE PATIENT SAMPLE WAS SENT BY THEIR CLIENT TO ANOTHER LABORATORY, AND THE PTH RESULT WAS LOWER. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP IPTH RESULTS. MDR 1219913-2018-00157 WAS FILED FOR A FALSELY ELEVATED RESULT ON (B)(6) 2018, AND MDR 1219913-2018-00158 WAS FILED FOR A FALSELY ELEVATED RESULT ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7568994 ↗
• MalfunctionJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FALSELY HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULTS WERE OBTAINED ON A PATIENT SAMPLE AND THE RESULTS WERE QUESTIONED BY THE PHYSICIAN. THE PATIENT HAD ELEVATED IPTH RESULTS ON DIFFERENT DAYS FROM THE SAME PATIENT. THE PHYSICIAN WAS EXPECTING A LOWER PTH RESULT, THE PATIENT SAMPLE WAS SENT BY THEIR CLIENT TO ANOTHER LABORATORY, AND THE PTH RESULT WAS LOWER. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP IPTH RESULTS. MDR 1219913-2018-00158 WAS FILED FOR A FALSELY ELEVATED RESULT ON (B)(6) 2018, AND MDR 1219913-2018-00159 WAS FILED FOR A FALSELY ELEVATED RESULT ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7568990 ↗
• MalfunctionJun 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FALSELY HIGH ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) RESULTS WERE OBTAINED ON A PATIENT SAMPLE AND THE RESULTS WERE QUESTIONED BY THE PHYSICIAN. THE PATIENT HAD ELEVATED IPTH RESULTS ON DIFFERENT DAYS FROM THE SAME PATIENT. THE PHYSICIAN WAS EXPECTING A LOWER PTH RESULT, THE PATIENT SAMPLE WAS SENT BY THEIR CLIENT TO ANOTHER LABORATORY, AND THE PTH RESULT WAS LOWER. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP IPTH RESULTS. MDR 1219913-2018-00157 WAS FILED FOR A FALSELY ELEVATED RESULT ON (B)(6) 2018, AND MDR 1219913-2018-00159 WAS FILED FOR A FALSELY ELEVATED RESULT ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7568979 ↗