BEUDAMED
    FDA Enforcement Class II Terminated

    CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics

    Recall: Z-2134-2021 · Reported August 4, 2021

    Enforcement

    Recall Number
    Z-2134-2021
    Event ID
    88138
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cytocell Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 4, 2021
    Initiation Date
    May 17, 2021
    Classification Date
    July 23, 2021
    Termination Date
    August 15, 2022
    Address
    418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, N/A, United Kingdom

    Description

    CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics

    Reason

    The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.

    Code Info

    Lot Numbers: 071399 072985

    Distribution

    Distribution to US states of CA, IL, MO, NY, PA, TX, and UT, and Canada.

    Quantity

    50