BEUDAMED
    FDA Enforcement Class III Terminated

    EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.

    Recall: Z-2749-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2749-2018
    Event ID
    80584
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard-Allan Scientific Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2018
    Initiation Date
    June 4, 2018
    Classification Date
    August 10, 2018
    Termination Date
    June 7, 2019
    Address
    4481 Campus Dr, Kalamazoo, MI, 49008-2590, United States

    Description

    EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.

    Reason

    Mislabeled product

    Code Info

    Lot # 17269A0

    Distribution

    US Nationwide Distribution

    Quantity

    1,039 cases/40 boxes per case