ADVIA Centaur® aTG 10492398Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414579214), received between Aug 1, 2018 and Jan 5, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K012777); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2022Low Test Results; Low Test Results

  DISCORDANT, LOW ADVIA CENTAUR XP ANTI-THYROGLOBULIN (ATG) ASSAY RESULTS WERE OBSERVED FOR TWO PATIENT SAMPLES IN A METHOD COMPARISON. THE INITIAL RESULTS FROM THE ADVIA CENTAUR XP ANALYZER WERE REPORTED TO THE PHYSICIAN, AND WERE NOT QUESTIONED. HOWEVER, REPEAT TESTING OF THE SAMPLES BY ALTERNATE METHODS PRODUCED CLINICALLY CONTRADICTORY RESULTS; THE REPEAT RESULTS WERE OBSERVED IN THE CONTEXT OF METHOD-COMPARISON TESTING, AND WERE NOT REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167803 ↗
• MalfunctionJan 5, 2022Low Test Results; Low Test Results

  DISCORDANT, LOW ADVIA CENTAUR XP ANTI-THYROGLOBULIN (ATG) ASSAY RESULTS WERE OBSERVED FOR TWO PATIENT SAMPLES IN A METHOD COMPARISON. THE INITIAL RESULTS FROM THE ADVIA CENTAUR XP ANALYZER WERE REPORTED TO THE PHYSICIAN, AND WERE NOT QUESTIONED. HOWEVER, REPEAT TESTING OF THE SAMPLES BY ALTERNATE METHODS PRODUCED CLINICALLY CONTRADICTORY RESULTS; THE REPEAT RESULTS WERE OBSERVED IN THE CONTEXT OF METHOD-COMPARISON TESTING, AND WERE NOT REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167798 ↗
• MalfunctionAug 1, 2018No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE NEGATIVE ADVIA CENTAUR XP ANTI-TG (ATG) RESULT WAS OBTAINED ON A PATIENT SAMPLE WHEN TESTED WITH REAGENT LOT 085304. THE NEGATIVE ATG RESULT WAS CONSIDERED DISCORDANT COMPARED TO AN INITIAL POSITIVE RESULT WITH REAGENT LOT 085298. THE INITIAL POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THESE DISCORDANT ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7739055 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012777. One submission often covers many models, so check the product and lot details in each record.

• Z-1236-2019 · Dec 7, 2018 · Terminated
  Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
• Z-1233-2019 · Dec 7, 2018 · Terminated
  Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
• Z-1234-2019 · Dec 7, 2018 · Terminated
  SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
• Z-1235-2019 · Dec 7, 2018 · Terminated
  Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461