BEUDAMED
    FDA Recall 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 · Initiated January 15, 2016

    Recall

    Recall Number
    Z-1509-2016
    Event Number
    73643
    Firm
    OraSure Technologies, Inc.
    FEI Number
    2528909
    Product Code
    MZO
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    January 15, 2016
    Terminated
    February 7, 2018
    Address
    1745 Eaton Ave, Bethlehem, PA, 18018-1769

    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.

    Action

    Letters, dated January 15, 2016, and correct HCV VRP insert were sent to all customers who received HCV VRP lot 6648737. The letter stated the reason for the recall; and, asked users to discard the Package Insert that was included with the product and replace it with the corrected one provided with the letter. Questions regarding the recall should be directed to OraSure Sales Representative or our Customer Care Department at 1-800-ORASURE.

    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