BEUDAMED
    FDA Recall Terminated

    PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.

    Recall: Z-1419-05 · Initiated April 13, 2005

    Recall

    Recall Number
    Z-1419-05
    Event Number
    32494
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GGW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 13, 2005
    Posted
    August 30, 2005
    Terminated
    October 3, 2006
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.

    Reason

    Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.

    Action

    On 4/13/2005, recall notification letters were sent to all customers and instructed them to stop using the kits and to dispose of the kits according to local regulations.

    Distribution

    The firm distributed this product to 32 clinics/laboratories/hospitals nationwide.

    Quantity

    740 kits