BEUDAMED
    FDA Recall Terminated

    STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method.

    Recall: Z-0408-06 · Initiated October 26, 2005

    Recall

    Recall Number
    Z-0408-06
    Event Number
    34011
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GGP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 26, 2005
    Posted
    January 20, 2006
    Terminated
    March 1, 2006
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method.

    Reason

    The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.

    Action

    Notification via recall letter was sent out on 10/26/2005. The letter was unsatisfactory and the letter was resent on 11/10/2005 as a recall letter.

    Distribution

    Product was distributed to 23 direct account customers nationwide.

    Quantity

    150 units