BEUDAMED
    FDA Enforcement Class III Terminated

    Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

    Recall: Z-1202-2019 · Reported May 1, 2019

    Enforcement

    Recall Number
    Z-1202-2019
    Event ID
    82599
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cytocell Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 1, 2019
    Initiation Date
    March 15, 2019
    Classification Date
    April 19, 2019
    Termination Date
    October 13, 2020
    Address
    Somerville Court, Unit 8, Banbury Business Park, Adderbury Banbury Oxfordshire, N/A, N/A, United Kingdom

    Description

    Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

    Reason

    There is an error in the chromomap included in the labeling for the product.

    Code Info

    Lot numbers: 056996 061156 062616 062808

    Distribution

    The products were distributed to the following US states: IL, TN.

    Quantity

    19