Dimension Vista Troponin I High Sensitive 10471067Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00842768037719), received between Jul 23, 2020 and Oct 23, 2024 — classified as 25 malfunctions.

The most frequently reported specific device problem is “High Test Results” (19 reports).

1 other recall cover devices cleared under the same FDA submission (K182225); 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED TWO (2) ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THE INITIAL ERRONEOUSLY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE REPROCESSED ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS NOT QUESTIONED UNTIL THE PATIENT WENT TO AN ALTERNATE LAB FACILITY AND HAD FURTHER SAMPLES DRAWN AND TESTED. TWO (2) NEW SAMPLES WERE DRAWN FROM THE SAME PATIENT AND PROCESSED ON AN ALTERNATE NON-SIEMENS SYSTEM AT AN ALTERNATE LAB FACILITY. LOWER TROPONIN RESULTS WERE OBTAINED AND CONSIDERED CORRECT BY THE PHYSICIAN(S) AT THE ORIGINAL LAB FACILITY, AND NO CORRECTED REPORT WAS ISSUED. THE PATIENT WAS ADMITTED TO AN EMERGENCY ROOM (ER) AND KEPT OVERNIGHT AT AN ALTERNATE LAB FACILITY DUE TO THE ELEVATED TNIH RESULTS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) RESULTS OR PATIENT ADMISSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513122 ↗
• MalfunctionJun 27, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED TWO (2) ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. ONE OF THE ERRONEOUSLY ELEVATED RESULTS WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS NOT QUESTIONED. THE PATIENT WAS SENT TO AN EMERGENCY ROOM (ER) AT ANOTHER FACILITY, AND NEW SAMPLES WERE DRAWN FROM THE SAME PATIENT. THE NEW (REDRAWN) SAMPLES WERE PROCESSED ON AN ALTERNATE NON-SIEMENS SYSTEM. LOWER TROPONIN RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. THE PATIENT WAS NOT ADMITTED WHEN SENT TO AN ER AT ANOTHER FACILITY BUT WAS KEPT FOR SEVERAL HOURS TO OBTAIN THE SERIAL TROPONIN MEASUREMENTS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS OR PATIENT TRANSFER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623777 ↗
• MalfunctionJun 12, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULT ON THE DIMENSION VISTA 1500 SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION VISTA 1500 SYSTEM AND ON AN ALTERNATE DIMENSION VISTA 1500 SYSTEM AND LOWER RESULTS WERE OBTAINED. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE ORIGINAL SYSTEM AND THE RESULT RECOVERED LOWER. THE CUSTOMER ALSO REPROCESSED ON AN ALTERNATE DIMENSION VISTA 1500 SYSTEM AND DID NOT PROVIDE THE RESULT. THE RESULT OF 6.3 PG/ML FROM THE NEWLY DRAWN SAMPLE WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT ON A PATIENT SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518392 ↗
• MalfunctionMar 14, 2024High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION VISTA 500 SYSTEM. ADDITIONALLY, TWO NEW SAMPLES WERE DRAWN FROM THE SAME PATIENT AND PROCESSED ON THE ORIGINAL DIMENSION VISTA 500 SYSTEM. THE REPROCESSED RESULTS AND THE NEW (REDRAWN) SAMPLE RESULTS OBTAINED WERE LOWER AND CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED PATIENT RESULT WITH HIGH-SENSITIVITY TROPONIN I (TNIH).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902991 ↗
• MalfunctionJun 16, 2023High Test Results; High Test Results

  TWO (2) ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON TWO (2) DIMENSION VISTA 500 SYSTEMS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. SUBSEQUENTLY, THE CUSTOMER DETERMINED THAT THE RESULTS WERE FALSELY ELEVATED. HOWEVER, THE SAMPLE WAS NOT REPROCESSED FURTHER, AND THE CUSTOMER STATED THAT NO CORRECT RESULT WAS OBTAINED OR REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144335 ↗
• MalfunctionJun 16, 2023High Test Results; High Test Results

  TWO (2) DISCORDANT FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON TWO (2) DIMENSION VISTA 500 SYSTEMS. THE FALSELY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE NON-SIEMENS SYSTEM USING TROPONIN I METHODOLOGY. A LOWER RESULT, CONSIDERED CORRECT, WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144329 ↗
• MalfunctionMay 13, 2022High Test Results; High Test Results

  TWO DISCORDANT FALSELY ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULTS FROM TWO SAMPLE DRAWS OF ONE PATIENT WERE OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE NON-SIEMENS SYSTEM (TROPONIN T METHOD). LOWER RESULTS WERE OBTAINED. THE LOWER RESULTS FROM THE NON-SIEMENS SYSTEM WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED TNIH PATIENT SAMPLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14394589 ↗
• MalfunctionMay 13, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED 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 TNIH PATIENT SAMPLE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14394574 ↗
• MalfunctionDec 30, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) PATIENT RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE FALSELY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED AFTER REMOVING THE CORRELATION FACTORS FOR THE TNIH ASSAY. A LOWER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNIH PATIENT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118271 ↗
• MalfunctionNov 16, 2021High Test Results; High Test Results

  DISCORDANT FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED AFTER REMOVAL OF CORRELATION FACTORS FOR THE TNIH ASSAY. LOWER RESULTS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED PATIENT TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820227 ↗
• MalfunctionNov 16, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED AFTER REMOVAL OF CORRELATION FACTORS FOR THE TNIH ASSAY. A LOWER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED PATIENT TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820209 ↗
• MalfunctionNov 7, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED AFTER REMOVAL OF CORRELATION FACTORS FOR THE TNIH ASSAY. A LOWER RESULT WAS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED PATIENT TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12761595 ↗
• MalfunctionNov 7, 2021High Test Results; High Test Results

  DISCORDANT FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULTS WERE OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED AFTER REMOVAL OF CORRELATION FACTORS FOR THE TNIH ASSAY. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED PATIENT TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760429 ↗
• MalfunctionOct 14, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED LOCI HIGH-SENSITIVITY TROPONIN I (TNIH) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 500 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE RESULT WAS QUESTIONED AND THE SAMPLE WAS REPROCESSED AFTER REMOVAL OF CORRELATION FACTORS OF THE TNIH ASSAY. A LOWER RESULT WAS OBTAINED AND A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED PATIENT TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12633253 ↗
• MalfunctionApr 16, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPROCESSED THE SAMPLES AFTER QUALITY CONTROL WAS DETECTED OUTSIDE OF LABORATORY ACCEPTANCE RANGE. LOWER RESULTS, CONSIDERED CORRECT, WERE OBTAINED. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TNIH RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680432 ↗
• MalfunctionMar 18, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE CUSTOMER REPROCESSED THE SAMPLE. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER STATED THAT THE PATIENT'S HOSPITALIZATION WAS PROLONGED DUE TO THE DISCORDANT TNIH RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE DISCORDANT TNIH RESULT OR THE PROLONGATION OF HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520277 ↗
• MalfunctionMar 18, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE CUSTOMER PROCESSED THE SAMPLE WITH AN ALTERNATE METHODOLOGY ON A NON-SIEMENS INSTRUMENT AND A LOWER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER STATED THAT THE PATIENT'S HOSPITALIZATION WAS PROLONGED DUE TO THE DISCORDANT TNIH RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE DISCORDANT TNIH RESULT OR THE PROLONGATION OF HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520258 ↗
• MalfunctionMar 18, 2021High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE CUSTOMER PROCESSED THE SAMPLE WITH AN ALTERNATE METHODOLOGY ON A NON-SIEMENS INSTRUMENT AND A LOWER RESULT WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER STATED THAT THE PATIENT'S HOSPITALIZATION WAS PROLONGED DUE TO THE DISCORDANT TNIH RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE DISCORDANT TNIH RESULT OR THE PROLONGATION OF HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520241 ↗
• MalfunctionAug 21, 2020High Test Results; High Test Results

  ELEVATED QUALITY CONTROL (QC) SAMPLE RESULTS WERE OBTAINED FOR HIGH SENSITIVITY TROPONIN I (TNIH) ON THE DIMENSION VISTA 1500 SYSTEM WHILE THE CUSTOMER WAS USING CORRELATION FACTORS SUPPLIED BY SIEMENS FOR TNIH LOT 20135BB. PATIENT SAMPLE RESULTS WERE REPORTED WHILE THE QUALITY CONTROL RESULTS WERE ELEVATED. NO PATIENT RESULTS WERE QUESTIONED BY PHYSICIANS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED HIGH SENSITIVITY TROPONIN I (TNIH) QC RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10439550 ↗
• MalfunctionAug 17, 2020Low Test Results; Low Test Results

  DISCORDANT LOW QUALITY CONTROL AND PATIENT SAMPLE RESULTS WERE OBTAINED DURING A NEW LOT COMPARISON STUDY FOR HIGH SENSITIVITY TROPONIN I (TNIH) ON THE DIMENSION VISTA 1500 SYSTEM. LOWER RESULTS WERE OBTAINED AFTER CALIBRATION OF NEW LOT 20135BB RELATIVE TO THE PREVIOUS LOT IN A CORRELATION STUDY. THE PATIENT COMPARISON STUDY RESULTS ON PATIENT CORRELATION SAMPLES WERE NOT REPORTED TO PHYSICIANS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW HIGH SENSITIVITY TROPONIN I (TNIH) QC AND PATIENT CORRELATION RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417600 ↗
• MalfunctionAug 7, 2020Low Test Results; Low Test Results

  DISCORDANT LOW RESULTS WERE OBTAINED DURING A NEW LOT COMPARISON STUDY FOR HIGH SENSITIVITY TROPONIN I (TNIH) ON THE DIMENSION VISTA 1500 SYSTEM. LOWER RESULTS WERE OBTAINED AFTER CALIBRATION OF NEW LOT 20008BB RELATIVE TO THE PREVIOUS LOT IN A CORRELATION STUDY. THE PATIENT COMPARISON STUDY RESULTS ON PATIENT CORRELATION SAMPLES WERE NOT REPORTED TO PHYSICIANS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW HIGH SENSITIVITY TROPONIN I (TNIH) PATIENT CORRELATION RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10380073 ↗
• MalfunctionAug 7, 2020Low Test Results; Low Test Results

  DISCORDANT LOW RESULTS WERE OBTAINED DURING A NEW LOT COMPARISON STUDY FOR HIGH SENSITIVITY TROPONIN I (TNIH) ON THE DIMENSION VISTA 1500 SYSTEM. LOWER RESULTS WERE OBTAINED AFTER CALIBRATION OF NEW LOT 20035BB RELATIVE TO THE PREVIOUS LOT IN A CORRELATION STUDY. THE PATIENT COMPARISON STUDY RESULTS ON PATIENT CORRELATION SAMPLES WERE NOT REPORTED TO PHYSICIANS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW HIGH SENSITIVITY TROPONIN I (TNIH) PATIENT CORRELATION RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379688 ↗
• MalfunctionAug 7, 2020Low Test Results; Low Test Results

  DISCORDANT LOW RESULTS WERE OBTAINED DURING A NEW LOT COMPARISON STUDY FOR HIGH SENSITIVITY TROPONIN I (TNIH) ON THE DIMENSION VISTA 1500 SYSTEM. LOWER RESULTS WERE OBTAINED AFTER CALIBRATION OF NEW LOT 20008BB RELATIVE TO THE PREVIOUS LOT IN A CORRELATION STUDY. THE PATIENT COMPARISON STUDY RESULTS ON PATIENT CORRELATION SAMPLES WERE NOT REPORTED TO PHYSICIANS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW HIGH SENSITIVITY TROPONIN I (TNIH) PATIENT CORRELATION RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379685 ↗
• MalfunctionJul 23, 2020Low Test Results; Low Test Results

  DISCORDANT LOW RESULTS WERE OBTAINED DURING A NEW LOT COMPARISON STUDY FOR HIGH SENSITIVITY TROPONIN I (TNIH) ON THE DIMENSION VISTA 1500 SYSTEM. LOWER RESULTS WERE OBTAINED AFTER CALIBRATION OF NEW LOT 20135BB RELATIVE TO THE PREVIOUS LOT IN STUDIES CONDUCTED ON TWO SYSTEMS. THE PATIENT COMPARISON STUDY RESULTS ON PATIENT CORRELATION SAMPLES WERE NOT REPORTED TO PHYSICIANS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW HIGH SENSITIVITY TROPONIN I (TNIH) PATIENT CORRELATION RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10315829 ↗
• MalfunctionJul 23, 2020Low Test Results; Low Test Results

  DISCORDANT LOW RESULTS WERE OBTAINED DURING A NEW LOT COMPARISON STUDY FOR HIGH SENSITIVITY TROPONIN I (TNIH) ON THE DIMENSION VISTA 1500 SYSTEM. LOWER RESULTS WERE OBTAINED AFTER CALIBRATION OF NEW LOT 20135BB RELATIVE TO THE PREVIOUS LOT IN STUDIES CONDUCTED ON TWO SYSTEMS. THE PATIENT COMPARISON STUDY RESULTS ON PATIENT CORRELATION SAMPLES WERE NOT REPORTED TO PHYSICIANS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW HIGH SENSITIVITY TROPONIN I (TNIH) PATIENT CORRELATION RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10315803 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182225. One submission often covers many models, so check the product and lot details in each record.

• Z-2927-2020 · Jul 24, 2020 · Terminated
  Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog