BEUDAMED
    FDA Recall 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 · Initiated July 24, 2020

    Recall

    Recall Number
    Z-2927-2020
    Event Number
    86151
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    MMI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 24, 2020
    Terminated
    June 7, 2023
    Address
    500 Gbc Dr, Newark, DE, 19702-2466

    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

    Action

    Siemens Healthcare issued Urgent Medical Device Correction (UMDC # VC-20-03.A.US) and Urgent Field Safety Notice (UFSN # VC-20-03.A.OUS) on July 24, 2020 to Dimension Vista customers who received the Dimension Vista TNIH reagent to notify them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to: "Review the letter with their Medical Director Use lot specific correlation factors with lots 20008BB, 20035BC, and 20135BB. Siemens is working to restore assay performance, until such time, subsequent lots may contain an alert card in the carton containing lot specific correlation factors ."Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. "If they have received any complaints of illness or adverse events associated with the product listed in Table 1 of the letter, immediately contact their local Siemens Remote Services Center or their local Siemens Technical Support Representative. Questions, please contact your Siemens Remote Services Center or your local Siemens Technical Support.

    Distribution

    Nationwide

    Quantity

    US: 1239 units OUS: 3387