BEUDAMED
    FDA Enforcement Class II Ongoing

    REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.

    Recall: Z-2078-2025 · Reported July 9, 2025

    Enforcement

    Recall Number
    Z-2078-2025
    Event ID
    96922
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton, Dickinson and Company, BD Bio Sciences
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 9, 2025
    Initiation Date
    June 3, 2025
    Classification Date
    July 3, 2025
    Address
    155 N Mccarthy Blvd, Milpitas, CA, 95035-5102, United States

    Description

    REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.

    Reason

    Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.

    Code Info

    Lot # 85612 & 85613/ UDI: 382903357758

    Distribution

    US: Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Hong Kong, India, Japan, South Korea, Mexico, Malaysia, Nepal, New Zealand, Peru, Pakistan, Singapore, El Salvador, Taiwan OUS:

    Quantity

    590 units