BEUDAMED
    FDA Enforcement Class II Ongoing

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

    Recall: Z-0743-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0743-2020
    Event ID
    84043
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Axis-Shield Diagnostics, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2020
    Initiation Date
    September 16, 2019
    Classification Date
    December 26, 2019
    Address
    17 Luna Place, Dundee, N/A, United Kingdom

    Description

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

    Reason

    There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

    Code Info

    UDI: 05055845400169; Lot Number 902924526

    Distribution

    US Nationwide distribution in the states of CA, KY.

    Quantity

    740 total