BEUDAMED
    FDA Recall 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 · Initiated March 15, 2015

    Recall

    Recall Number
    Z-1454-2015
    Event Number
    70856
    Firm
    Focus Diagnostics Inc
    FEI Number
    2023365
    Product Code
    OYP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 15, 2015
    Posted
    April 17, 2015
    Terminated
    July 23, 2015
    Address
    11331 Valley View St, Cypress, CA, 90630-5366

    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.

    Action

    Focus Diagnostics sent an Urgent Device Customer Notification letter dated March 15, 2015, was sent to the customer to inform them that Focus Diagnostics is recalling the Stratify JCV DxSelect (EL1950) lot#27333 due to the potential for false positive JCV results. The letter informs the customer of the issues and the actions to be taken. The customer is instructed to complete the enclosed acknowledgement form and email the form to [email protected] or fax back to Focus Diagnostics Technical Services at (562) 240-6526 within 10 business days. If the customer has any questions or require additional information, then they are instructed to contact Focus Diagnostic's Technical Services department at (800) 838-4548, select option 3, between the hours of 7am to 5pm (PST) or send an email to [email protected].

    Distribution

    Internationally: Denmark only.

    Quantity

    300 units