BEUDAMED
    FDA Recall Terminated

    Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.

    Recall: Z-0015-2008 · Initiated July 24, 2007

    Recall

    Recall Number
    Z-0015-2008
    Event Number
    39389
    Firm
    Thermo Fisher Scientific
    FEI Number
    2550000
    Product Code
    JIF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 24, 2007
    Posted
    October 4, 2007
    Terminated
    December 18, 2007
    Address
    171 Industry Dr, Pittsburgh, PA, 15275-1015

    Description

    Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.

    Reason

    Method is susceptible to positive interference from endogenous ALT in patient samples.

    Action

    The firm has updated the Limitations section of the Ammonia Reagent Package Insert and circulated a Technical Bulletin dated July 24, 2007 to all customers that have purchased Ammonia Reagent that is still within expiration date. A Notification of Change has been introduced and shall be placed within subsequent Ammonia Reagent Kits with a copy of the updated package insert; the notification of change informs customers that a change has been made to the package insert. Notifications of Change are placed within kits for 6 months from the date of issue.

    Distribution

    Worldwide, including USA, Ecuador, and Canada.

    Quantity

    6,882 units