BEUDAMED
    FDA Enforcement Class II 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 Number K6427, SMN# 104471067

    Recall: Z-2927-2020 · Reported September 9, 2020

    Enforcement

    Recall Number
    Z-2927-2020
    Event ID
    86151
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2020
    Initiation Date
    July 24, 2020
    Classification Date
    September 2, 2020
    Termination Date
    June 7, 2023
    Address
    500 Gbc Dr, N/A, Newark, DE, 19702-2466, United States

    Description

    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 Number K6427, SMN# 104471067

    Reason

    Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples

    Code Info

    Lot # 20008BB UDI: 0084276803771920135BB21031010471067840; Lot #20035BC UDI:0084276803771920035BC20113010471067840; Lot #20135BB UDI: 0084276803771920008BB20110310471067840

    Distribution

    Nationwide

    Quantity

    US: 1239 units OUS: 3387