BEUDAMED
    FDA Recall Terminated

    Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory component for Dynex Technologies proprietary automated DSX system.

    Recall: Z-1082-04 · Initiated June 11, 2004

    Recall

    Recall Number
    Z-1082-04
    Event Number
    29421
    Firm
    Dynex Technologies, Inc.
    FEI Number
    1117676
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 11, 2004
    Posted
    July 20, 2004
    Terminated
    August 18, 2004
    Address
    14340 Sullyfield Cir, Chantilly, VA, 20151-1621

    Description

    Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory component for Dynex Technologies proprietary automated DSX system.

    Reason

    An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.

    Action

    The recalling firm notified consignees by faxed letter on 6/11/04 and follow-up letter by mail 6/24/04. The notice advised of vacuum failure associated with lot 412410 of sample tips and recommended quarantine of the defective tips. Consignees were requested to return response form. The 6/24/04 notification recommends that consignees discard/destroy lot 412410 and asks distributors to notify their customers. The firm is working with supplier of the pipette tips to replace recalled product.

    Distribution

    Pipette tips were sold to seven OEMs for distribution to end users in the US and internationally.

    Quantity

    1749 cartons