BEUDAMED
    FDA Enforcement Class II Ongoing

    Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481

    Recall: Z-1493-2021 · Reported May 5, 2021

    Enforcement

    Recall Number
    Z-1493-2021
    Event ID
    87621
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cytocell Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 5, 2021
    Initiation Date
    March 19, 2021
    Classification Date
    April 26, 2021
    Address
    418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, N/A, N/A, United Kingdom

    Description

    Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481

    Reason

    Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.

    Code Info

    Lot: RD20/253/16, RD21/043/01, RD21/043/02

    Distribution

    US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.

    Quantity

    89 probes