BEUDAMED
    FDA Enforcement Class II Terminated

    Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests

    Recall: Z-1231-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1231-2017
    Event ID
    76337
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quidel Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2017
    Initiation Date
    January 25, 2017
    Classification Date
    February 22, 2017
    Termination Date
    June 2, 2017
    Address
    10165 McKellar Ct, N/A, San Diego, CA, 92121-4201, United States

    Description

    Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests

    Reason

    Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.

    Code Info

    PS10171

    Distribution

    Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX

    Quantity

    1,010 packages