BEUDAMED
    FDA Enforcement Class II Terminated

    Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

    Recall: Z-1685-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1685-2017
    Event ID
    76619
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Focus Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2017
    Initiation Date
    February 15, 2017
    Classification Date
    March 27, 2017
    Termination Date
    April 13, 2017
    Address
    11331 Valley View St, Cypress, CA, 90630-5366, United States

    Description

    Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

    Reason

    After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.

    Code Info

    Unique Device Identifier IF0950: 20816101020045, lot numbers 30244, 30928, 31288, 31642, 32331, 32562, 32850

    Distribution

    Product was distributed to three testing laboratories in California, New Jersey and Virginia

    Quantity

    196 units