BEUDAMED
    FDA Recall 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 · Initiated March 13, 2015

    Recall

    Recall Number
    Z-1329-2015
    Event Number
    70668
    Firm
    Lusys Laboratories, Inc.
    FEI Number
    3004473533
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    March 13, 2015
    Posted
    April 9, 2015
    Terminated
    May 31, 2017
    Address
    10054 Mesa Ridge Ct, Ste 118-120, San Diego, CA, 92121-2946

    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.

    Action

    LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688. For questions regarding this recall call 858-546-0902.

    Distribution

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

    Quantity

    1,015 units