BEUDAMED
    FDA Enforcement Class II Terminated

    Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.

    Recall: Z-2829-2020 · Reported August 26, 2020

    Enforcement

    Recall Number
    Z-2829-2020
    Event ID
    86084
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cytocell Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 26, 2020
    Initiation Date
    July 17, 2020
    Classification Date
    August 20, 2020
    Termination Date
    September 30, 2020
    Address
    418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, N/A, United Kingdom

    Description

    Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.

    Reason

    A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.

    Code Info

    Lot numbers: 069915, 070433, 069305, 069468

    Distribution

    Worldwide distribution - US Nationwide distribution and the country of Canada.

    Quantity

    62 units