Atellica IM TNIHRecalls & reported problems across all models

We found 2 models of Atellica IM TNIH by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 629 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2019 and Sep 17, 2026 — classified as 629 malfunctions.

The most frequently reported specific device problem is “High Test Results” (598 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Atellica IM TNIH problems

Atellica IM TNIH models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Atellica IM TNIH 10997841

  IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  463 reports
• Atellica IM TNIH 10997840

  IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  166 reports

Recent Atellica IM TNIH adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810360 ↗
• MalfunctionSep 17, 2026High Test Results

  The customer reports observation of elevated Atellica IM High-Sensitivity Troponin I (TnIH) results which were discordant relative to alternate-method testing when using TnIH lot 115.An initial elevated Atellica IM TnIH result was observed for a 16-year-old male patient. The same sample was re-tested and again produced an elevated TnIH result.The sample was tested again using a Roche Troponin-T assay, and a result below that assay¿s cutoff was obtained. This lower result was accepted as correct, and the Atellica IM TnIH results were identified as falsely elevated. There are no allegations of any adverse patient consequences in association with the observed result discordance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805152 ↗
• MalfunctionMay 15, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING LOT# 113. INITIAL ELEVATED RESULTS WERE OBTAINED FOR THREE PATIENT SAMPLES FROM THE EMERGENCY ROOM (ER) DEPARTMENT. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE ANALYZER WHICH PRODUCED LOWER RESULTS. THE LOWER RESULTS WERE CONSIDERED CORRECT AND CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187294 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150548 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150547 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT: 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150546 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150545 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150544 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER OBSERVED THAT ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) LOT 113 RESULTS FOR A PATIENT DID NOT DECREASE OVER TIME AS EXPECTED FOR A PATIENT WHO WAS DIAGNOSED AND TREATED FOR ACUTE MYOCARDIAL INFARCTION (AMI). ALTERNATE METHOD RESULTS FOR THIS PATIENT ARE LOWER, BUT STILL ABOVE THE METHOD REFERENCE RANGE/CUTOFF. THE PATIENT WAS CORRECTLY DIAGNOSED AND TREATED, BUT THE ATELLICA IM TNIH RESULTS ARE NOT DROPPING ACROSS MULTIPLE DAYS OF TESTING. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150542 ↗
• MalfunctionMay 6, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING WHEN USING TNIH LOT 114. AN INITIAL ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR A 28-YEAR-OLD FEMALE PATIENT. NEW SAMPLES WERE DRAWN AND TESTED ON THE FOLLOWING TWO DAYS, AND EACH SAMPLE PRODUCED AN ELEVATED TNIH RESULT. THE PHYSICIAN QUESTIONED THESE ELEVATED RESULTS, AND THE PATIENT¿S SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING USING AN ALTERNATE METHOD (ROCHE). THE ALTERNATE-METHOD RESULT WAS MUCH LOWER (NEAR OR BELOW CUTOFF), AND CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION. THE ATELLICA IM TNIH RESULTS WERE IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE. NOTE: EACH OBSERVATION OF AN ERRONEOUS ATELLICA IM TNIH RESULT IS REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094006 ↗
• MalfunctionMay 6, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING WHEN USING TNIH LOT 114. AN INITIAL ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR A 28-YEAR-OLD FEMALE PATIENT. NEW SAMPLES WERE DRAWN AND TESTED ON THE FOLLOWING TWO DAYS, AND EACH SAMPLE PRODUCED AN ELEVATED TNIH RESULT. THE PHYSICIAN QUESTIONED THESE ELEVATED RESULTS, AND THE PATIENT¿S SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING USING AN ALTERNATE METHOD (ROCHE). THE ALTERNATE-METHOD RESULT WAS MUCH LOWER (NEAR OR BELOW CUTOFF) AND CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION. THE ATELLICA IM TNIH RESULTS WERE IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE. NOTE: EACH OBSERVATION OF AN ERRONEOUS ATELLICA IM TNIH RESULT IS REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094005 ↗
• MalfunctionMay 5, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING WHEN USING TNIH LOT 114. AN ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR AN 88-YEAR-OLD FEMALE PATIENT. THE PATIENT¿S SAMPLE WAS RE-TESTED USING AN ALTERNATE METHOD (AFIAS SYSTEM), WHICH PRODUCED A RESULT BELOW CUTOFF. THE INITIAL TNIH RESULT WAS IDENTIFIED AS FALSELY ELEVATED. WHEN THE SAMPLE WAS RE-TESTED FOR INVESTIGATION PURPOSES ON THE ATELLICA IM PLATFORM THREE DAYS LATER, IT AGAIN PRODUCED A SIMILARLY ELEVATED RESULT. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE. NO ISSUES WERE IDENTIFIED WITH QUALITY CONTROL (QC) RESULTS AT THE TIME OF THESE OBSERVATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25080219 ↗
• MalfunctionApr 27, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT 113. AN ELEVATED INITIAL ATELLICA IM TNIH RESULT WAS OBSERVED FOR A 43-YEAR-OLD MALE PATIENT WITH NO HISTORY OF CARDIAC ISSUES. ANOTHER SAMPLE WAS DRAWN AND TESTED AN HOUR LATER IN THE EMERGENCY ROOM, AND THE RESULT WAS BELOW ASSAY MEASURING RANGE (<2.5 NG/ML). WHEN THE INITIAL SAMPLE WAS RE-TESTED, IT PRODUCED A SIMILAR LOW RESULT. THE LOW TROPONIN RESULTS WERE REPRODUCED IN REPEAT TESTING. THE INITIAL RESULT WAS IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997367 ↗
• MalfunctionApr 23, 2026High Test Results

  THE CUSTOMER OBTAINED AN ELEVATED ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH) RESULT (> 99TH%ILE) ON A PATIENT SAMPLE THAT WAS DISCORDANT COMPARED TO A RESULT OBTAINED ON AN ALTERNATE TEST METHOD. ATELLICA IM TNIH REAGENT LOT 113 WAS IN USE AT THE TIME. THE INITIAL ATELLICA IM TNIH RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN BECAUSE IT WAS ELEVATED BASED ON THE PATIENT'S CLINICAL STATUS (DETAILS WERE NOT PROVIDED). THE SAMPLE WAS SENT TO ANOTHER LAB FOR ALTERNATE METHOD TESTING AND THE RESULT WAS LOWER, BUT ALSO GREATER THAN THE METHOD'S REFERENCE INTERVAL. THIS LOWER RESULT WAS CONSIDERED CORRECT. AND CONSIDERED CORRECT. ANOTHER SAMPLE FROM THE SAME PATIENT WAS DRAWN AND TESTED AT A DIFFERENT LAB ON A DIFFERENT ATELLICA IM ANALYZER FOR COMPARISON. THE RESULT WAS ELEVATED AND SIMILAR TO THE INITIAL ATELLICA IM TNIH RESULT AT THE CUSTOMER SITE. THERE ARE NO ALLEGATIONS OF ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968348 ↗
• MalfunctionApr 22, 2026High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING TNIH LOT: 113. AN ELEVATED ATELLICA IM TNIH RESULT WAS OBSERVED FOR AN 87-YEAR-OLD MALE PATIENT. THIS RESULT WAS NOT TRANSMITTED TO THE DOCTOR. WHEN THE SAME SAMPLE WAS RE-TESTED TWICE ON THE SAME INSTRUMENT, MUCH LOWER RESULTS WERE PRODUCED. A SIMILAR LOW RESULT WAS OBTAINED WHEN THE SAMPLE WAS REPEAT TESTED ON ANOTHER ATELLICA IM INSTRUMENT; THIS RESULT WAS REPORTED AS CORRECT. THE INITIAL RESULT WAS IDENTIFIED AS FALSELY ELEVATED. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED RESULT DISCORDANCE. QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES JUST BEFORE THIS SAMPLE WAS RUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952293 ↗

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