BEUDAMED
    FDA Enforcement Class III Terminated

    Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.

    Recall: Z-0932-2021 · Reported February 3, 2021

    Enforcement

    Recall Number
    Z-0932-2021
    Event ID
    87098
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fujifilm Medical Systems U.S.A., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 3, 2021
    Initiation Date
    December 22, 2020
    Classification Date
    January 28, 2021
    Termination Date
    July 20, 2021
    Address
    81 Hartwell Ave Ste 300, Lexington, MA, 02421-3160, United States

    Description

    Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.

    Reason

    FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all product manufactured as part of Lot EL629. This may result incorrect results when used in testing.

    Code Info

    Lot EL629, Model 990-28011

    Distribution

    US Nationwide distribution including in the states of MO, OR, MD, PA.

    Quantity

    10 boxes (4 units per box)