BEUDAMED
    FDA Enforcement Class III Terminated

    Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13 and acts as a control probe.

    Recall: Z-1843-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1843-2019
    Event ID
    82917
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cytocell Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 26, 2019
    Initiation Date
    April 26, 2019
    Classification Date
    June 19, 2019
    Termination Date
    July 16, 2020
    Address
    418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, N/A, United Kingdom

    Description

    Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13 and acts as a control probe.

    Reason

    There is an error in the chromomap on the package insert.

    Code Info

    Lot Numbers: 058585, 061111, 061354, 062527

    Distribution

    Worldwide Distribution - US Nationwide AL, CO, FL, HI, IA, IL, IN, KY, MA, MD, MI, MO, MS, NC, NJ, NY, TN, TX, UT, WA, and WI. The products were distributed to the following foreign countries: Canada.

    Quantity

    400