Dimension Cardiac Troponin-I Flex reagent cartridge 10444896Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00842768013904), received between Nov 28, 2017 and Sep 12, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 reports).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K010313); 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.

Recalls naming this device

1. May 18, 2022Class IITerminated

   Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 g/L], may lead to inappropriate intervention for myocardial infarction

   Z-1340-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN I (LTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION XPAND PLUS WITH HM SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS SENT TO AN ALTERNATE FACILITY WHERE A NEW SAMPLE WAS DRAWN AND PROCESSED ON AN ALTERNATE SIEMENS SYSTEM. A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED LTNI PATIENT RESULT OR THE TRANSFER TO AN ALTERNATE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401068 ↗
• MalfunctionJun 29, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN-I (LTNI) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION XPAND PLUS WITH HM SYSTEM. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S). THE FALSELY ELEVATED RESULT WAS OBTAINED ON A PLASMA SAMPLE (LITHIUM HEPARIN) OF THE PATIENT SAMPLE DRAW. A SERUM SAMPLE FROM THE SAME PATIENT DRAW WAS PROCESSED ON THE NEXT DAY ON THE SAME DIMENSION XPAND PLUS WITH HM SYSTEM. A LOWER RESULT WAS OBTAINED AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. SERIAL TROPONIN TESTING WAS ALSO DONE AT AN ALTERNATE FACILITY, ON A NON-SIEMENS SYSTEM USING AN ALTERNATE METHODOLOGY FOR TROPONIN. LOWER RESULTS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED LTNI PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851486 ↗
• MalfunctionMay 10, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN-I (LTNI) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION XPAND PLUS WITH HM SYSTEM. THE DISCORDANT FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS SENT TO AN ALTERNATE FACILITY WHERE A NEW SAMPLE WAS DRAWN AND PROCESSED ON AN ALTERNATE SIEMENS SYSTEM. A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED LTNI PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345965 ↗
• MalfunctionApr 27, 2022High Test Results; High Test Results

  FOUR (4) DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN-I (LTNI) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION XPAND WITH HM SYSTEM. THE DISCORDANT FALSELY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN FOR TWO OF THE FOUR SAMPLES. THE PHYSICIAN QUESTIONED ONE OF THE PATIENT SAMPLE RESULTS. ONE PATIENT WAS SENT TO A HOSPITAL FOR A NEW SAMPLE TO BE DRAWN AND PROCESSED. A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED LTNI PATIENT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES TO THE PATIENT SENT TO THE ALTERNATE FACILITY FOR TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220193 ↗
• MalfunctionApr 22, 2022High Test Results; High Test Results

  DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN-I (LTNI) PATIENT SAMPLE RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES ON A DIMENSION XPAND WITH HM SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON A NON-SIEMENS INSTRUMENT ON THE SAME DATE AND LOWER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. THE TWO (2) SAMPLES WERE INITIALLY PROCESSED ON THE NON-SIEMENS INSTRUMENT AND LOWER RESULTS, CONSIDERED CORRECT, WERE OBTAINED AND REPORTED PREVIOUSLY. THEREFORE, NO CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN-I (LTNI) PATIENT SAMPLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14186124 ↗
• MalfunctionMar 31, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED CARDIAC TROPONIN-I (LTNI) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION XPAND PLUS WITH HM SYSTEM. THE DISCORDANT FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN DID NOT BELIEVE THE RESULT. THE SAMPLE WAS NOT REPROCESSED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED LTNI PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13965640 ↗
• MalfunctionOct 15, 2019Non Reproducible Results; Non Reproducible Results

  A DELAY OF REPORTING A PATIENT RESULT FOR CARDIAC TROPONIN I (LTNI) OCCURRED ON THE DIMENSION XPAND PLUS W/HM INSTRUMENT. THE RESULTS OBTAINED ON THE DIMENSION XPAND PLUS W/HM INSTRUMENT WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS TESTED AT AN ALTERNATE FACILITY WITH A NON-SIEMENS METHODOLOGY AND A NEGATIVE RESULT WAS OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAYED LTNI RESULT REPORTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9194572 ↗
• MalfunctionNov 28, 2017High Test Results; High Test Results

  A DISCORDANT ELEVATED CARDIAC TROPONIN I (LTNI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION XPAND PLUS HM INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE FACILITY FOR MONITORING. NEW SAMPLES WERE TESTED WITH AN ALTERNATE SIEMENS METHODOLOGY AND LOWER CARDIAC TROPONIN I RESULTS WERE OBTAINED ON THE SAME PATIENT. THERE ARE NO HARM TO THE PATIENT. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED LTNI RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7065327 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010313. One submission often covers many models, so check the product and lot details in each record.

• Z-1731-2009 · Apr 8, 2008 · Terminated
  Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro d
• Z-0858-2010 · Mar 2, 2007 · Terminated
  Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521. Intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized