BEUDAMED
    FDA Enforcement Class II Terminated

    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

    Recall: Z-2323-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2323-2021
    Event ID
    88294
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cytocell Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 25, 2021
    Initiation Date
    May 27, 2021
    Classification Date
    August 18, 2021
    Termination Date
    May 9, 2022
    Address
    418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, N/A, United Kingdom

    Description

    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

    Reason

    May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34

    Code Info

    Lots 073004 and 072518 (Probe lot 200918-006).

    Distribution

    US Nationwide distribution in the states of CA, IL, KY, NY, OH, TX, UT, VA.

    Quantity

    23 units