BEUDAMED
    FDA Recall Terminated

    Dimension Vista IRON Flex reagent cartridges

    Recall: Z-0401-2017 · Initiated August 25, 2016

    Recall

    Recall Number
    Z-0401-2017
    Event Number
    75256
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JIY
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    August 25, 2016
    Terminated
    December 1, 2017
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension Vista 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).

    Action

    Siemens mailed an Urgent Medical Device Correction letter to all customers who received the Dimension and Dimension Vista IRON Flex reagent with an update to the Limitation of Procedure section for the Dimension and Dimension Visa IRON assays Instructions For Use (IFU) to indicate that: patients treated with metal-binding drugs (e.g. deferoxamine) may have depressed iron values, as chelated iron may not properly react in the iron assay. Customers were told that the information provided in the letter, related to deferoxamine, supersedes the information related to deferoxamine int he current IRON IFU's for Dimension and Dimension Vista products until the IFU's are updated.

    Distribution

    Distributed Nationwide

    Quantity

    30,247 units