BEUDAMED
    FDA Enforcement Class II Terminated

    Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.

    Recall: Z-0238-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0238-2016
    Event ID
    72395
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Focus Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    October 2, 2015
    Classification Date
    November 6, 2015
    Termination Date
    January 29, 2016
    Address
    11331 Valley View St, N/A, Cypress, CA, 90630-5366, United States

    Description

    Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.

    Reason

    Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.

    Code Info

    26341, 27011

    Distribution

    Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia

    Quantity

    38 kits