ADVIA Centaur® aTG 10492399Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414579221), received between Jun 20, 2018 and Jun 20, 2018 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE NEGATIVE ADVIA CENTAUR XP ANTI-TG (ATG) RESULT WAS OBTAINED ON A PATIENT SAMPLE WHEN TESTED WITH REAGENT LOT 085298. THE LOW ATG RESULT WAS CONSIDERED DISCORDANT COMPARED TO AN INITIAL POSITIVE RESULT WITH REAGENT LOT 085295. THE INITIAL POSITIVE RESULT WAS IN AGREEMENT WITH THE CLINICAL PICTURE OF THE PATIENT, AND THE RESULT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP ATG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7620572 ↗

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