BEUDAMED
    FDA Enforcement Class II Terminated

    Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

    Recall: Z-0077-2019 · Reported October 17, 2018

    Enforcement

    Recall Number
    Z-0077-2019
    Event ID
    80932
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumentation Laboratory Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2018
    Initiation Date
    August 1, 2018
    Classification Date
    October 5, 2018
    Termination Date
    April 16, 2019
    Address
    180 Hartwell Rd, Bedford, MA, 01730-2443, United States

    Description

    Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

    Reason

    There is a potential for increased imprecision, out of range quality controls and prolonged sample results.

    Code Info

    Lot Number - N0278177 Exp. Date February 28, 2019

    Distribution

    US Nationwide

    Quantity

    9751 kits