BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1066-2018 · Initiated October 25, 2017

    Recall

    Recall Number
    Z-1066-2018
    Event Number
    79292
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 25, 2017
    Terminated
    May 12, 2020
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    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%).

    Action

    Stago sent an Urgent Field Safety Notice letter dated October 25, 2017 to their customers. The letter identified the affected product, problem and actions to be taken: Customers were instructed to: If it is not already done, run a Quality Control test at every change of vial (if you have affected lots of product). Return to company, by fax or email, an acknowledgement form confirming that the recall letter was read by the receiving company. For questions contact the Stago Hotline (1-800-725-0607).

    Distribution

    Nationally

    Quantity

    1636 Kits