BEUDAMED
    FDA Enforcement Class II Terminated

    CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

    Recall: Z-0341-2023 · Reported December 7, 2022

    Enforcement

    Recall Number
    Z-0341-2023
    Event ID
    91119
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cytocell Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 7, 2022
    Initiation Date
    October 27, 2022
    Classification Date
    November 30, 2022
    Termination Date
    December 27, 2024
    Address
    418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, United Kingdom

    Description

    CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

    Reason

    An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.

    Code Info

    Lot Number: RD22/230/11

    Distribution

    TX

    Quantity

    3 units