BEUDAMED
    FDA Recall Terminated

    Dimension Vista HbA1c

    Recall: Z-0127-2015 · Initiated August 14, 2014

    Recall

    Recall Number
    Z-0127-2015
    Event Number
    69334
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    LCP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 14, 2014
    Posted
    October 24, 2014
    Terminated
    August 10, 2015
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    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

    Action

    An Urgent Medical Device Correction, dated August 2014, was provided to all Dimension Vista HbA1c customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers.

    Distribution

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

    Quantity

    20043