BEUDAMED
    FDA Enforcement Class III Ongoing

    Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

    Recall: Z-0984-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0984-2022
    Event ID
    89655
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2022
    Initiation Date
    February 16, 2022
    Classification Date
    April 21, 2022
    Address
    11800 Sw 147th Ave, Miami, FL, 33196-2500, United States

    Description

    Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

    Reason

    IRISpec CA failures for glucose.

    Code Info

    Lot #583-21 and higher, UDI 10837461002611.

    Distribution

    Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.

    Quantity

    12,306 kits