Atellica IM aTG 10995461Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414597881), received between Jan 4, 2021 and Jan 4, 2021 — classified as 1 malfunction.

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

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.

• MalfunctionJan 4, 2021Low Test Results; Low Test Results

  DISCORDANT LOW, ANTI-THYROGLOBULIN (ATG) PATIENT SAMPLE RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER WITH A DIFFERENT LOT OF REAGENT AND A HIGHER RESULT WAS OBTAINED. THE REPEAT RESULT WAS REPORTED, AS THE CORRECTED RESULT, TO THE PHYSICIAN. THE PHYSICIAN DID NOT QUESTION THE RESULT. 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 11108115 ↗

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