BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    Recall: Z-2563-2025 · Reported September 24, 2025

    Enforcement

    Recall Number
    Z-2563-2025
    Event ID
    97421
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Agilent Technologies Denmark ApS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    September 24, 2025
    Initiation Date
    August 11, 2025
    Classification Date
    September 15, 2025
    Address
    42 PRODUKTIONSVEJ, N/A, Glostrup, N/A, N/A, Denmark

    Description

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    Reason

    Their is the potential for weak staining which may result in false negative CD20 identification.

    Code Info

    Lot number: 41700704, 41810164, UDI: 05700572033042

    Distribution

    US Nationwide distribution including in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

    Quantity

    4145