Atellica IM TnI-Ultra 10995696Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414600093), received between Sep 26, 2019 and Jul 8, 2021 — classified as 6 malfunctions.

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

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2021No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER'S ON-HAND ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA) ASSAY REAGENTS REACHED THEIR EXPIRATION DATING BEFORE RESUPPLY WAS OBTAINED. AS A RESULT, THE CUSTOMER REPORTED A DELAY IN THE AVAILABILITY OF TROPONIN TESTING. THERE IS NO ALLEGATION OF ANY EFFECT ON PATIENT TREATMENT, AND NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139743 ↗
• MalfunctionJun 17, 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. THE SAME SAMPLE WAS REPEATED ON THE ORIGINAL ATELLICA IM SYSTEM AND ON ANOTHER ATELLICA IM SYSTEM, ALL RESULTING LOWER. THE LOWER TNI-ULTRA RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECT 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 Known Impact Or Consequence To Patient

  MAUDE report 10165618 ↗
• MalfunctionFeb 6, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A CUSTOMER OBTAINED ONE DISCORDANT (ELEVATED) RESULT ON ONE PATIENT SAMPLE DRAW (DRAW #2) WITH ATELLICA IM TROPONIN I ULTRA (TNI-ULTRA) COMPARED TO REPEAT RESULT FROM THE SAME SAMPLE AND THE RESULTS OF DIFFERENT SAMPLE DRAWS FROM THE SAME PATIENT AND VERSUS AN ALTERNATE METHOD. NO ISSUES WERE OBSERVED WITH ANY OTHER PATIENTS REGARDING ATELLICA IM TNL-ULTRA. THE CUSTOMER BELIEVES THAT THE DISCORDANT RESULT WAS DUE TO THE SPECIFIC SAMPLE. PATIENT TREATMENT WAS NOT PRESCRIBED, ALTERED OR DELAYED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9678562 ↗
• MalfunctionJan 21, 2020No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT HIGH ATELLICA IM 1300 ANALYZER TROPONIN I ULTRA (TNI-ULTRA) RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENT SAMPLES WERE REPEATED AND THE RESULTS WERE LOWER. THE PATIENTS WERE ADMITTED TO THE HOSPITAL BASED ON THE INITIAL HIGH RESULT. NO TREATMENT WAS ALTERED OR PRESCRIBED BASED ON THE RESULTS. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH ATELLICA IM TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9611560 ↗
• MalfunctionJan 21, 2020No Apparent Adverse Event; No Apparent Adverse Event

  DISCORDANT HIGH ATELLICA IM 1300 ANALYZER TROPONIN I ULTRA (TNI-ULTRA) RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENT SAMPLES WERE REPEATED AND THE RESULTS WERE LOWER. THE PATIENTS WERE ADMITTED TO THE HOSPITAL BASED ON THE INITIAL HIGH RESULT. NO TREATMENT WAS ALTERED OR PRESCRIBED BASED ON THE RESULTS. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH ATELLICA IM TNI-ULTRA RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9611542 ↗
• MalfunctionSep 26, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED A LOW ATELLICA IM 1300 TROPONIN I ULTRA (TNI-ULTRA) RESULT THAT DID NOT MATCH REPEAT TESTING OR THE CLINICAL PICTURE OF THE PATIENT. THE LOW RESULT WAS REPORTED THE PHYSICIAN WHO QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ATELLICA IM 1300 TNI-ULTRA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9126099 ↗

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