BEUDAMED
    FDA Enforcement Class III Terminated

    TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A

    Recall: Z-0814-2022 · Reported March 30, 2022

    Enforcement

    Recall Number
    Z-0814-2022
    Event ID
    89669
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cytocell Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 30, 2022
    Initiation Date
    February 4, 2022
    Classification Date
    March 21, 2022
    Termination Date
    November 6, 2024
    Address
    418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, N/A, United Kingdom

    Description

    TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A

    Reason

    May show unexpected locus specific signals in addition to those at 14q32.

    Code Info

    Lot 074612

    Distribution

    MN

    Quantity

    1 unit