BEUDAMED
    FDA Enforcement Class II Ongoing

    RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.

    Recall: Z-2210-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2210-2023
    Event ID
    92586
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cytocell Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2023
    Initiation Date
    May 24, 2023
    Classification Date
    July 20, 2023
    Address
    418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, N/A, United Kingdom

    Description

    RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.

    Reason

    DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

    Code Info

    Catalog No. LPS509-A; UDI-DI: 05055844900516; Lot No. 076764, 080124, 082129, 082560, 083247, 083550, 083850.

    Distribution

    US Nationwide distribution in the states of CA, FL, OH, & SC.

    Quantity

    61 units