BEUDAMED
    FDA Recall Terminated

    Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

    Recall: Z-0819-2013 · Initiated December 3, 2012

    Recall

    Recall Number
    Z-0819-2013
    Event Number
    64017
    Firm
    Quidel Corporation
    FEI Number
    2024674
    Product Code
    GNX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 3, 2012
    Posted
    February 14, 2013
    Terminated
    January 31, 2014
    Address
    10165 Mckellar Ct, San Diego, CA, 92121-4201

    Description

    Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

    Reason

    Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.

    Action

    Quidel Corporation sent a Medical Device Recall dated December 3, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and remove the affected product from their inventory. Customers should contact Quide Corporation for instructions on how to obtain replacement product. Customers were instructed to fax the enclosed inventory Form to Quidel at 858-552-7905. For technical support customers should call 800-874-1517 or 858-552-1100. For questions regarding this recall call 858-552-1100, ext 7922.

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK

    Quantity

    13,090 kits (327,250 tests)