BEUDAMED
    FDA Recall Terminated

    Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use.

    Recall: Z-2117-2010 · Initiated March 15, 2010

    Recall

    Recall Number
    Z-2117-2010
    Event Number
    55226
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 15, 2010
    Posted
    August 2, 2010
    Terminated
    August 3, 2010
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use.

    Reason

    Vessel pick up errors and vessel jams when the vessel is being loaded. The error halts the instrument and disrupts processing. Vessel flange is thin.

    Action

    Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated March 2010 informing users of the potential problem, to discard any remaining product, and if needed, to request a replacement lot.

    Distribution

    Worldwide distribution: USA, Canada, Europe, Japan, Korea, and New Zealand.

    Quantity

    5544 bags