BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0238-2016 · Initiated October 2, 2015

    Recall

    Recall Number
    Z-0238-2016
    Event Number
    72395
    Firm
    Focus Diagnostics Inc
    FEI Number
    2023365
    Product Code
    OTT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 2, 2015
    Posted
    November 6, 2015
    Terminated
    January 29, 2016
    Address
    11331 Valley View St, Cypress, CA, 90630-5366

    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.

    Action

    A recall letter dated 10/2/15 was sent to distributors who distributed the Anaplasma phagocytophilum IFA IgM (IF1450M) kit lots 26431 and 27011. The letter informs the customers that Focus Diagnostics received customer complaints of IF1450M with low reactivity, which may result in higher invalid rate. The letter also provides the customers with Focus Diagnostics' recommendations and actions to be taken by the distributors. Customers with questions or require additional information are instructed to contact Focus Diagnostics' Technical Services department at (562) 240-6550 from 7am to 5pm (PST) or send an email to [email protected].

    Distribution

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

    Quantity

    38 kits