BEUDAMED
    FDA Recall 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 · Initiated January 25, 2017

    Recall

    Recall Number
    Z-1231-2017
    Event Number
    76337
    Firm
    Quidel Corporation
    FEI Number
    2024674
    Product Code
    OCC
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    January 25, 2017
    Posted
    February 22, 2017
    Terminated
    June 2, 2017
    Address
    10165 McKellar Ct, San Diego, CA, 92121-4201

    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.

    Action

    Quidel sent an Urgent Medical Device Recall letter dated 1/25/17 to all affected customers and distributors to inform them that Quidel is recalling the Influenza Transport Swab Packages because they may contain incorrect sample swab mixed in with the proper swabs. The letter informs the customers that the standard influenza swab is packaged individually, one (1) swab per package and uses a polyurethane foam tip. The incorrect swab is packaged as two (2) swabs per individual package and uses a rayon fiber tip. Customers are instructed to complete the enclosed Inventory Assessment/Certificate of Destruction form and return to Quidel. Contact Quidel Technical Support at [email protected] or by calling 800.874.1517 (in the U.S.), or 858.552.1100 (outside the U.S.), for instructions on how to obtain replacement product. Our hours of operation are Monday through Friday, 7:00 a.m. to 5:00 p.m. Pacific Time.

    Distribution

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

    Quantity

    1,010 packages