BEUDAMED
    FDA Recall Terminated

    STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ Phone 800-abc coag 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex

    Recall: Z-1072-2007 · Initiated May 8, 2007

    Recall

    Recall Number
    Z-1072-2007
    Event Number
    37952
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GGP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 8, 2007
    Posted
    August 9, 2007
    Terminated
    October 13, 2010
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ Phone 800-abc coag 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex

    Reason

    Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.

    Action

    Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled " Recall notice, Open Immediately"

    Distribution

    Medical facilities nationwide

    Quantity

    365 units