ADVIA Centaur PTHRecalls & reported problems across all models
Siemens Healthcare Diagnostics Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of ADVIA Centaur PTH by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Feb 15, 2018 and Oct 17, 2025 — classified as 24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ADVIA Centaur PTH problems
Device problems
- No Apparent Adverse Event13
- Adverse Event Without Identified Device or Use Problem8
- High Test Results3
Patient problems
- No Known Impact Or Consequence To Patient21
- No Clinical Signs, Symptoms or Conditions3
ADVIA Centaur PTH models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ADVIA Centaur® PTH 10699154RADIOIMMUNOASSAY, PARATHYROID HORMONE17 reports
- ADVIA Centaur® PTH 10699155RADIOIMMUNOASSAY, PARATHYROID HORMONE7 reports
Recent ADVIA Centaur PTH adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Siemens Healthcare Diagnostics Inc. products
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- ADVIA Centaur XP Analyzer2 models · 269 reports
- ADVIA Centaur CA 19-92 models · 124 reports · 2 recalls
- Atellica IM eE23 models · 65 reports · 3 recalls
- RAPIDPoint 500 Measurement Cartridge4 models · 3 reports · 4 recalls
- ADVIA Centaur eE23 models · 22 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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