BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0341-2023 · Initiated October 27, 2022

    Recall

    Recall Number
    Z-0341-2023
    Event Number
    91119
    Firm
    Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom
    FEI Number
    3002646096
    Product Code
    MVU
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 27, 2022
    Posted
    November 30, 2022
    Terminated
    December 27, 2024

    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.

    Action

    CytoCell issued Urgent Medical Device Recall letter on 10/27/22 to end user via email. The letter states reason for recall, health risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that all users review and implement the enclosed new package insert (v2) for this device. Please dispose of any copies of v1 of the package insert. Please complete and return the enclosed response form as soon as possible. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or [email protected].

    Distribution

    TX

    Quantity

    3 units