BEUDAMED
    FDA Recall Open, Classified

    Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A

    Recall: Z-0089-2023 · Initiated August 24, 2022

    Recall

    Recall Number
    Z-0089-2023
    Event Number
    90872
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JHM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 24, 2022
    Posted
    October 14, 2022
    Address
    500 Gbc Dr, Newark, DE, 19702-2466

    Description

    Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A

    Reason

    Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.

    Action

    Siemens issued an Urgent Medical Device Correction (UMDC) mailed to US affected customers by FedEx beginning on 08/24/2022. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 08/24/2022. Letter states: Discontinue use of and discard the lot listed in Table 1. Review your inventory of this lot to determine your laboratory s replacement needs and to provide information to Siemens for reporting to the Authorities. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days to Siemens Healthineers for reporting to the Authorities. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative.

    Distribution

    Nationwide Foreign: Canada

    Quantity

    1592 units