BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1685-2017 · Initiated February 15, 2017

    Recall

    Recall Number
    Z-1685-2017
    Event Number
    76619
    Firm
    Focus Diagnostics Inc
    FEI Number
    2023365
    Product Code
    LHL
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    February 15, 2017
    Posted
    March 27, 2017
    Terminated
    April 13, 2017
    Address
    11331 Valley View St, Cypress, CA, 90630-5366

    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.

    Action

    Focus Diagnostics/DiaSorin Molecular is issuing a medical device correction for the Legionella IFA (Immuno Fluoresence Assay). On February 1, 2017, the firm was notified that the Legionella IFA was not properly classified according to 21 CFR Part 807. The product is being withdrawn from the market. Use of the product should be immediately discontinued, and any remaining inventory should be immediately destroyed. The firm sent notice to its consignees, which should be reviewed with the facility's laboratory or mediclal director. Patient results obtained with all lots of the affected product should be evaluated by the clinician and if recommended, retested by another method.

    Distribution

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

    Quantity

    196 units