ADVIA Centaur® TSH3-UL 10282378Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414535647), received between Aug 4, 2017 and Aug 31, 2017 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE LOW ADVIA CENTAUR XP TSH3-ULTRA ((TSH3-UL) RESULT WAS OBTAINED BY THE CUSTOMER, AND THE RESULT WAS QUESTIONED BY THE CLINICIAN. THE PATIENT SAMPLE WAS TESTED FOR TSH ON THE ADVIA CENTAUR XP, AND THE RESULT WAS NORMAL. THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY, TESTED FOR TSH ON AN ALTERNATE TEST METHOD (SIEMENS IMMULITE), AND THE RESULT WAS NORMAL. THE PATIENT SAMPLE WAS REPEATED AT THE ORIGINAL LABORATORY ON A SECOND ALTERNATE TSH TEST METHOD, AND THE RESULT WAS NORMAL. THE CUSTOMER PERFORMED REPEAT TSH3-UL TESTING OF THE PATIENT SAMPLE AND THE RESULT WAS LOW. THE ALTERNATE TSH TEST METHOD RESULTS WERE REPORTED TO THE PHYSICIAN. 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 6835646 ↗
• MalfunctionAug 4, 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 OBTAINED ON A PATIENT SAMPLE. THE PHYSICIAN WAS EXPECTING A HIGHER TSH VALUE, AND QUESTIONED THE RESULT. THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY, TESTED ON AN ALTERNATE TSH TEST METHOD, AND THE RESULT WAS HIGHER. THE PHYSICIAN SUSPECTS A POTENTIAL SAMPLE INTERFERENT. 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 6768131 ↗

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