BEUDAMED
    FDA Enforcement Class II Terminated

    HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate

    Recall: Z-0736-2016 · Reported February 10, 2016

    Enforcement

    Recall Number
    Z-0736-2016
    Event ID
    72972
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumentation Laboratory Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 10, 2016
    Initiation Date
    December 18, 2015
    Classification Date
    February 1, 2016
    Termination Date
    August 30, 2017
    Address
    180 Hartwell Rd, N/A, Bedford, MA, 01730-2443, United States

    Description

    HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate

    Reason

    This Lot is not meeting labeled on-board instrument stability claims of 5 days.

    Code Info

    Lot No. N0455811, Expiration Date 03/31/2017

    Distribution

    Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela.

    Quantity

    Domestic: 108 kits, Foreign: 197 kits