BEUDAMED
    FDA Enforcement Class III Terminated

    Dimension IRON Flex reagent cartridges

    Recall: Z-0402-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0402-2017
    Event ID
    75256
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2016
    Initiation Date
    August 25, 2016
    Classification Date
    November 11, 2016
    Termination Date
    December 1, 2017
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Dimension IRON Flex reagent cartridges

    Reason

    Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).

    Code Info

    Device Listing # D011391 Lot # DB6267, FD6309, FB6310,BA7006,BB7006,GB7060,BA7116,EC7200 Exp Date: 09/23/2016-0-7/19/2017

    Distribution

    Distributed Nationwide

    Quantity

    38,230 cartridges