BEUDAMED
    FDA Enforcement Class III Terminated

    OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.

    Recall: Z-1509-2016 · Reported April 27, 2016

    Enforcement

    Recall Number
    Z-1509-2016
    Event ID
    73643
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    OraSure Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2016
    Initiation Date
    January 15, 2016
    Classification Date
    April 18, 2016
    Termination Date
    February 7, 2018
    Address
    1745 Eaton Ave, N/A, Bethlehem, PA, 18018-1769, United States

    Description

    OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.

    Reason

    OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel.

    Code Info

    Item Number 1001-0343, Lot # 6648737

    Distribution

    Nationwide Distribution -- AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI.

    Quantity

    244 Visual Reference Panel Kits