BEUDAMED
    FDA Enforcement Class II Terminated

    CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781

    Recall: Z-0353-2023 · Reported December 7, 2022

    Enforcement

    Recall Number
    Z-0353-2023
    Event ID
    91117
    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
    December 1, 2022
    Termination Date
    December 27, 2024
    Address
    418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, United Kingdom

    Description

    CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781

    Reason

    Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert

    Code Info

    Lot RD22/230/10

    Distribution

    TX