BEUDAMED
    FDA Enforcement Class II Terminated

    Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024

    Recall: Z-0741-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0741-2022
    Event ID
    89602
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cytocell Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 16, 2022
    Initiation Date
    January 18, 2022
    Classification Date
    March 9, 2022
    Termination Date
    November 8, 2024
    Address
    418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, N/A, United Kingdom

    Description

    Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024

    Reason

    individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control probe labelled in red rather than green. The expected positive signal pattern in the case of 1x deleted 5q will be 1G2R instead of 1R2G, an incorrect result

    Code Info

    Lot Number: 075711 Exp. Date: 2023-06-22 UDI: (01)05055844901551(17)230622(10)075 711

    Distribution

    US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania, Tennessee.

    Quantity

    19 kits