ADVIA Centaur® TSH3-UL 10282379Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00630414535654), received between Oct 5, 2017 and Feb 17, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K083844); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A DISCORDANT, FALSELY DEPRESSED THYROID STIMULATING HORMONE RESULT FOR THE ADVIA CENTAUR XPT TSH3-ULTRA (TSH3-UL) ASSAY WHEN COMPARED TO THE PATIENT'S CLINICAL PICTURE AND REPEAT RESULTS FROM THE SAME SAMPLE. THE PATIENT IS BEING TREATED FOR HYPERTHYROIDISM. THE INITIAL ADVIA CENTAUR XPT TSH3-UL RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE DEPRESSED RESULT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DEPRESSED ADVIA CENTAUR XPT TSH3-UL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13551903 ↗
• MalfunctionFeb 14, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY LOW ADVIA CENTAUR TSH3-ULTRA (TSH3-UL) RESULTS WERE OBTAINED ON PATIENT SAMPLES. THE RESULTS WERE CONSIDERED DISCORDANT COMPARED WITH THE TSH ASSAY RESULT, AND THE RESULTS OBTAINED FROM OTHER ALTERNATE TSH TEST METHODS. THE CUSTOMER INDICATED THAT HISTORICALLY, THE ADVIA CENTAUR TSH3-ULTRA RESULTS HAVE BEEN LOW. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9711595 ↗
• MalfunctionFeb 14, 2020No Apparent Adverse Event; No Apparent Adverse Event

  FALSELY LOW ADVIA CENTAUR TSH3-ULTRA (TSH3-UL) RESULTS WERE OBTAINED ON PATIENT SAMPLES. THE RESULTS WERE CONSIDERED DISCORDANT COMPARED WITH THE TSH ASSAY RESULT, AND THE RESULTS OBTAINED FROM OTHER ALTERNATE TSH TEST METHODS. THE CUSTOMER INDICATED THAT HISTORICALLY, THE ADVIA CENTAUR TSH3-ULTRA RESULTS HAVE BEEN LOW. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9711594 ↗
• MalfunctionDec 4, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE LOW ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) RESULT WAS OBTAINED FOR A PATIENT SAMPLE COMPARED TO THE CLINICAL PICTURE AND THE ADVIA CENTAUR XP TSH ASSAY. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR XP TSH3-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9412202 ↗
• MalfunctionNov 7, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE LOW ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) RESULT WAS OBTAINED FOR A PATIENT SAMPLE COMPARED TO THE CLINICAL PICTURE AND THE ADVIA CENTAUR XP TSH ASSAY. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR XP TSH3-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9291258 ↗
• MalfunctionNov 7, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE LOW ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) RESULT WAS OBTAINED FOR A PATIENT SAMPLE COMPARED TO THE CLINICAL PICTURE AND THE ADVIA CENTAUR XP TSH ASSAY. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR XP TSH3-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9291255 ↗
• MalfunctionJan 23, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE LOW ADVIA CENTAUR XP TSH3-ULTRA ((TSH3-UL) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS CONSIDERED DISCORDANT WITH THE TSH ASSAY. THE RESULT WAS HIGHER FOR TSH. THE SAMPLE WAS ALSO TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS HIGHER THAN THE TSH3-ULTRA RESULT. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8271158 ↗
• MalfunctionJan 23, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE LOW ADVIA CENTAUR XP TSH3-ULTRA ((TSH3-UL) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS CONSIDERED DISCORDANT WITH THE TSH ASSAY. THE RESULT WAS HIGHER FOR TSH. THE SAMPLE WAS ALSO TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS HIGHER THAN THE TSH3-ULTRA RESULT. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8271147 ↗
• MalfunctionSep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FALSE LOW ADVIA CENTAUR TSH3-ULTRA ((TSH3-UL) RESULTS WERE OBSERVED BY THE CUSTOMER, AND CONSIDERED DISCORDANT WHEN COMPARED TO ALTERNATE TSH TEST METHODS, AND THE ADVIA CENTAUR TSH ASSAY. THE CUSTOMER HAD RUN 20 SAMPLES, AND THREE OF THE TSH3-UL RESULTS DID NOT MATCH WHEN COMPARED TO THE TSH RESULTS. THE DISCORDANT TSH3-UL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TSH3-ULTRA RESULTS. MDR 1219913-2018-00220 WAS FILED FOR FALSE LOW RESULTS FOR ORIGINAL SAMPLES TESTED ON A DIFFERENT REAGENT LOT (114314). MDR 1219913-2018-00221 WAS FILED FOR A FALSE LOW RESULT FOR A DIFFERENT SAMPLE TESTED ON A DIFFERENT REAGENT LOT (114319).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852742 ↗
• MalfunctionSep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FALSE LOW ADVIA CENTAUR TSH3-ULTRA ((TSH3-UL) RESULTS WERE OBSERVED BY THE CUSTOMER, AND CONSIDERED DISCORDANT WHEN COMPARED TO ALTERNATE TSH TEST METHODS, AND THE ADVIA CENTAUR TSH ASSAY. THE CUSTOMER HAD RUN 20 SAMPLES, AND THREE OF THE TSH3-UL RESULTS DID NOT MATCH WHEN COMPARED TO THE TSH RESULTS. THE DISCORDANT TSH3-UL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TSH3-ULTRA RESULTS. MDR 1219913-2018-00221 WAS FILED FOR A FALSE LOW RESULT FOR A DIFFERENT SAMPLE TESTED ON A DIFFERENT LOT (114319). MDR 1219913-2018-00222 WAS FILED FOR A FALSE LOW RESULT WHEN THE ORIGINAL SAMPLE ((B)(6)) WAS REPEATED ON A DIFFERENT REAGENT LOT (114316).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852741 ↗
• MalfunctionSep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FALSE LOW ADVIA CENTAUR TSH3-ULTRA ((TSH3-UL) RESULTS WERE OBSERVED BY THE CUSTOMER, AND CONSIDERED DISCORDANT WHEN COMPARED TO ALTERNATE TSH TEST METHODS, AND THE ADVIA CENTAUR TSH ASSAY. THE CUSTOMER HAD RUN 20 SAMPLES, AND THREE OF THE TSH3-UL RESULTS DID NOT MATCH WHEN COMPARED TO THE TSH RESULTS. THE DISCORDANT TSH3-UL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TSH3-ULTRA RESULTS. MDR 1219913-2018-00220 WAS FILED FOR FALSE LOW RESULTS FOR DIFFERENT SAMPLES TESTED ON A DIFFERENT REAGENT LOT (114314). MDR 1219913-2018-00222 WAS FILED FOR A FALSE LOW RESULT WHEN SAMPLE (B)(6) WAS REPEATED ON A DIFFERENT REAGENT LOT (114316).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852740 ↗
• MalfunctionJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE LOW ADVIA CENTAUR TSH3-ULTRA ((TSH3-UL) RESULT WAS OBSERVED ON A PATIENT SAMPLE WHEN THE CUSTOMER PERFORMED VERIFICATION TESTING AFTER QUALITY CONTROL RESULTS WERE OUT OF RANGE DUE TO A NEW REAGENT READYPACK PLACED ON THE SYSTEM. IT IS THE LABORATORY'S PROTOCOL TO REPEAT ALL TESTED SAMPLES FROM WHEN QC WAS LAST ACCEPTABLE TO WHEN QC WAS OUT OF RANGE. A CALIBRATION OF TSH3-ULTRA ASSAY WAS PERFORMED WITH THE NEW REAGENT READYPACK PLACED ON THE SYSTEM, AND QC WAS ACCEPTABLE. THE PATIENT SAMPLE WAS REPEATED AND HIGHER RESULTS WERE OBTAINED. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE ADVIA CENTAUR SYSTEM AND THE RESULT WAS HIGHER THAN ORIGINALLY REPORTED. A CORRECTED REPORT WAS ISSUED. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TSH3-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7681439 ↗
• MalfunctionNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT LOW ADVIA CENTAUR XPT TSH3-ULTRA (TSH3-UL) RESULTS WERE OBTAINED FOR SAMPLES FROM TWO PATIENTS. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLES WERE REPEATED AND THE EXPECTED RESULTS WERE OBTAINED. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7067597 ↗
• MalfunctionNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT LOW ADVIA CENTAUR XPT TSH3-ULTRA (TSH3-UL) RESULTS WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLE WAS REPEATED AND THE EXPECTED RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TSH3-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7067592 ↗
• MalfunctionOct 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE LOW ADVIA CENTAUR TSH3-ULTRA ((TSH3-UL) RESULT WAS OBTAIN ON A PATIENT ((B)(6)). THE PHYSICIAN WAS EXPECTING A RESULT WITHIN THE NORMAL RANGE, AND QUESTIONED THE LOW RESULT. THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY, TESTED ON AN ALTERNATE TSH TEST METHOD, AND THE RESULT WAS HIGHER. THE PATIENT HAD BEEN PREVIOUSLY TESTED ON THE ADVIA CENTAUR XP FOR TSH3-UL BY THIS CUSTOMER, AND THE RESULT WAS FALSELY LOW. BASED ON THE ORIGINAL TSH3-UL RESULT, THE PHYSICIAN HAD ORDER A NEW SAMPLE DRAW ON THE SAME PATIENT. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TSH3-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6918761 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083844. One submission often covers many models, so check the product and lot details in each record.

• Z-1654-2014 · Apr 10, 2014 · Terminated
  ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determ
• Z-1653-2014 · Apr 10, 2014 · Terminated
  ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determi
• Z-1881-2013 · May 10, 2013 · Terminated
  ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulatin
• Z-2313-2012 · Jul 25, 2012 · Terminated
  Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Ca