BEUDAMED
    FDA Recall Terminated

    TASWako Chip Cassette is part of the Wako TASWako i30 kit

    Recall: Z-1412-2021 · Initiated February 18, 2021

    Recall

    Recall Number
    Z-1412-2021
    Event Number
    87507
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    FEI Number
    1000513161
    Product Code
    NSF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 18, 2021
    Terminated
    February 24, 2022
    Address
    81 Hartwell Ave, Ste 300, Lexington, MA, 02421-3160

    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

    Action

    Fujifilm issued Consignee notifications via courier delivery and electronic mail on February 18, 2021. The letter states reason for recall, health risk and action to take: FUJIFILM is recommending that you immediately cease use of any Cavity #2 chips in Lot EQ194 and return the product to FUJIFILM. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken: Upon receipt of the Field Action Verification Form, FUJIFILM will provide replacement chip cassette boxes (each containing 5 x 20 chips) from a different lot. Please contact our field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at [email protected], if you have any further questions regarding this field action.

    Distribution

    CA, LA, MN, NC, UT, WI

    Quantity

    496 units