BEUDAMED
    FDA Recall Terminated

    Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy. Slider allows a larger label to be applied to the ESR tube.

    Recall: Z-1816-2010 · Initiated April 12, 2010

    Recall

    Recall Number
    Z-1816-2010
    Event Number
    55535
    Firm
    Vital Diagnostics, Inc.
    FEI Number
    1717966
    Product Code
    GHC
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    April 12, 2010
    Posted
    June 22, 2010
    Terminated
    September 13, 2010
    Address
    27 Wellington Rd, Lincoln, RI, 02865-4411

    Description

    Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy. Slider allows a larger label to be applied to the ESR tube.

    Reason

    The tube may fall out or separate from the Slider adapter

    Action

    Vital Diagnostics issued recall letter dated April 14, 2010 via Certified Mail in an envelop marked "Urgent Recall Information Inside", requesting accounts to discontinue use and destroy recalled product. A Certificate of Destruction and Refund Form was included to direct customers. A second Distributor Notice was sent by email to the distributors with Important Recall Information in the title. This was accompanied with the same Technical Bulletin, Certificate of Destruction and Refund Form. For further information, contact Vital Diagnostics at 1-800-345-2822.

    Distribution

    Distributed Nationwide and Canada.

    Quantity

    4,723 units