BEUDAMED
    FDA Enforcement Class II Terminated

    STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).

    Recall: Z-1069-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-1069-2018
    Event ID
    79292
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnostica Stago, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    October 25, 2017
    Classification Date
    March 15, 2018
    Termination Date
    May 12, 2020
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607, United States

    Description

    STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).

    Reason

    Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

    Code Info

    Lot: 250041RX (Exp: 2018-02) Lot: 250077 (Exp: 2018-02) Lot: 250246RU (Exp: 2018-03) Lot: 251492 (Exp: 2018-09) Lot: 251308 (Exp: 2018-10) Lot: 251626 (Exp: 20 19-01) Lot: 251730 (Exp: 2019-02) Lot: 251772 (Exp: 2019-02)

    Distribution

    Nationally