BEUDAMED
    FDA Enforcement Class II Terminated

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

    Recall: Z-1946-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1946-2015
    Event ID
    70992
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Axis-Shield Diagnostics, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 8, 2015
    Initiation Date
    March 20, 2015
    Classification Date
    July 2, 2015
    Termination Date
    October 27, 2015
    Address
    The Technology Park, Luna Place, Dundee, N/A, United Kingdom

    Description

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

    Reason

    Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.

    Code Info

    Part Number/Lot Number: FHBC100/802899574; FHRWR100/802899249; FHRWR1000/802899248; FHRWR200/802899989; FHRWR200/802899250; FHRWCN1/802900104

    Distribution

    Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.

    Quantity

    52 kits + 75 kits Beckman Coulter Brand OUS