BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0819-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0819-2013
    Event ID
    64017
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quidel Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2013
    Initiation Date
    December 3, 2012
    Classification Date
    February 14, 2013
    Termination Date
    January 31, 2014
    Address
    10165 Mckellar Ct, San Diego, CA, 92121-4201, United States

    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.

    Code Info

    Lot # Range: 208228-214385, 707916-708108 (29 lots).

    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)