BEUDAMED
    FDA Enforcement Class II Terminated

    Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).

    Recall: Z-1066-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-1066-2018
    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

    Neoplastine¿ Cl Plus @ (ref.00374) 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 115080 (Exp: 01-2018) Lot 251241 (Exp: 01-2018)

    Distribution

    Nationally

    Quantity

    1636 Kits