Atellica IM TnI-Ultra 10995697Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414600109), received between Oct 28, 2020 and Nov 22, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K053020); 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.

• MalfunctionNov 22, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA) RESULTS WHICH WERE DISCORDANT RELATIVE TO THE PATIENT'S CLINICAL PICTURE. THE ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN. SUBSEQUENT RE-TESTING OF THE PATIENT USING ALTERNATE TEST METHODS PRODUCED LOWER RESULTS WHICH WERE ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15846767 ↗
• MalfunctionNov 22, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA) RESULTS WHICH WERE DISCORDANT RELATIVE TO THE PATIENT'S CLINICAL PICTURE. THE ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN. SUBSEQUENT RE-TESTING OF THE PATIENT USING ALTERNATE TEST METHODS PRODUCED LOWER RESULTS WHICH WERE ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15846656 ↗
• MalfunctionOct 28, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND QUESTIONED BY THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED TWICE, RESULTING LOWER. THE LOWER TNI-ULTRA RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10752155 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053020. One submission often covers many models, so check the product and lot details in each record.

• Z-2041-2016 · May 2, 2016 · Terminated
  Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determina
• Z-2207-2015 · May 19, 2015 · Terminated
  ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponi
• Z-1991-2014 · May 30, 2014 · Terminated
  ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
• Z-0580-2008 · Jun 7, 2007 · Terminated
  ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solu