BEUDAMED
    FDA Enforcement Class II Terminated

    ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit

    Recall: Z-1412-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1412-2021
    Event ID
    87507
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 21, 2021
    Initiation Date
    February 18, 2021
    Classification Date
    April 12, 2021
    Termination Date
    February 24, 2022
    Address
    81 Hartwell Ave Ste 300, N/A, Lexington, MA, 02421-3160, United States

    Description

    ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit

    Reason

    Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result

    Code Info

    Lot Number: EQ194 Exp. Date: 05/31/2022

    Distribution

    CA, LA, MN, NC, UT, WI

    Quantity

    496 units