BEUDAMED
    FDA Enforcement Class I Terminated

    OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.

    Recall: Z-2403-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2403-2016
    Event ID
    74843
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    OraSure Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 24, 2016
    Initiation Date
    July 20, 2016
    Classification Date
    August 17, 2016
    Termination Date
    May 10, 2017
    Address
    1745 Eaton Ave, N/A, Bethlehem, PA, 18018-1769, United States

    Description

    OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.

    Reason

    Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.

    Code Info

    Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.

    Distribution

    Distributed to one customer only in US state of Georgia.

    Quantity

    3,075 units