BEUDAMED
    FDA Enforcement Class II Terminated

    STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.

    Recall: Z-1454-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1454-2015
    Event ID
    70856
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Focus Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    March 15, 2015
    Classification Date
    April 17, 2015
    Termination Date
    July 23, 2015
    Address
    11331 Valley View St, Cypress, CA, 90630-5366, United States

    Description

    STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.

    Reason

    Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false positive JCV results.

    Code Info

    Lot No. 27333

    Distribution

    Internationally: Denmark only.

    Quantity

    300 units