BEUDAMED
    FDA Enforcement Class II Terminated

    Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.

    Recall: Z-1144-2014 · Reported March 12, 2014

    Enforcement

    Recall Number
    Z-1144-2014
    Event ID
    67436
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Focus Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 12, 2014
    Initiation Date
    February 4, 2014
    Classification Date
    March 5, 2014
    Termination Date
    November 1, 2014
    Address
    11331 Valley View St, Cypress, CA, 90630-5366, United States

    Description

    Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.

    Reason

    Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.

    Code Info

    Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.

    Distribution

    Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.

    Quantity

    2,175 kits