BEUDAMED
    FDA Enforcement Class I Terminated

    Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.

    Recall: Z-1334-2015 · Reported April 15, 2015

    Enforcement

    Recall Number
    Z-1334-2015
    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 Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.

    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

    n/a

    Distribution

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

    Quantity

    5 units