BEUDAMED
    FDA Recall Terminated

    Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.

    Recall: Z-0189-2012 · Initiated October 3, 2011

    Recall

    Recall Number
    Z-0189-2012
    Event Number
    60059
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    CDQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 3, 2011
    Posted
    November 16, 2011
    Terminated
    May 11, 2012
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038-4313

    Description

    Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.

    Reason

    The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus species.

    Action

    The firm decided to recall and they sent a Product Recall Letter to their customers on 10/03/2011. Questions regarding the letter should be directed to Customer Service at 1-877-4ABBOTT for US customers, and customers outside of the US should contact their local area Customer Service. Customers should determine if you have any remaining inventory. Please discontinue and destroy any remaining inventory of these lots. Order alternative lots of Clinical Chemistry Urea Nitrogen. Complete and return the enclosed Customer Reply form.

    Distribution

    Worldwide Distribution.

    Quantity

    5704 units of Urea Nitrogen