BEUDAMED
    FDA Enforcement Class III Terminated

    Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

    Recall: Z-0824-2022 · Reported March 30, 2022

    Enforcement

    Recall Number
    Z-0824-2022
    Event ID
    89747
    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 14, 2022
    Classification Date
    March 24, 2022
    Termination Date
    June 12, 2023
    Address
    418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, N/A, United Kingdom

    Description

    Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

    Reason

    Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the outer label.

    Code Info

    Lot 210511-018

    Distribution

    US Nationwide distribution in the states of CT, TX.

    Quantity

    5 kits