BEUDAMED
    FDA Enforcement Class II Ongoing

    BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

    Recall: Z-0777-2023 · Reported January 11, 2023

    Enforcement

    Recall Number
    Z-0777-2023
    Event ID
    91175
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 11, 2023
    Initiation Date
    November 18, 2022
    Classification Date
    January 3, 2023
    Address
    11800 Sw 147th Ave, N/A, Miami, FL, 33196-2500, United States

    Description

    BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

    Reason

    Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

    Code Info

    UDI/DI 10837461002611, Lot 565-21: 11-30-2022

    Distribution

    US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan

    Quantity

    3657 units