BEUDAMED
    FDA Enforcement Class II Terminated

    Dimension Vista¿ HbA1c

    Recall: Z-0127-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0127-2015
    Event ID
    69334
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    August 14, 2014
    Classification Date
    October 24, 2014
    Termination Date
    August 10, 2015
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Dimension Vista¿ HbA1c

    Reason

    In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t

    Code Info

    catalog #K3105A, material #10470481, All in-date lots

    Distribution

    Worldwide Distribution: US (nationwide) and country of: Canada.

    Quantity

    20043