BEUDAMED
    FDA Enforcement Class I Terminated

    Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.

    Recall: Z-1329-2015 · Reported April 15, 2015

    Enforcement

    Recall Number
    Z-1329-2015
    Event ID
    70668
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Lusys Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 15, 2015
    Initiation Date
    March 13, 2015
    Classification Date
    April 9, 2015
    Termination Date
    May 31, 2017
    Address
    10054 Mesa Ridge Ct Ste 118-120, N/A, San Diego, CA, 92121-2946, United States

    Description

    Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.

    Reason

    LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.

    Code Info

    Lot No. 12012014B

    Distribution

    Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.

    Quantity

    1,015 units