BEUDAMED
    FDA Enforcement Class II Terminated

    Pathfast D-Dimer, Reference number: PF1051-KUS

    Recall: Z-0646-2017 · Reported November 30, 2016

    Enforcement

    Recall Number
    Z-0646-2017
    Event ID
    75511
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lsi Medience Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 30, 2016
    Initiation Date
    August 16, 2016
    Classification Date
    November 21, 2016
    Termination Date
    February 27, 2017
    Address
    13-4 Uchikanda 1 Chome, N/A, Tokyo, N/A, N/A, Japan

    Description

    Pathfast D-Dimer, Reference number: PF1051-KUS

    Reason

    Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.

    Code Info

    Lot T528

    Distribution

    US Distribution to the states of : AL, FL, ID and MA.

    Quantity

    42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).