BEUDAMED
    FDA Enforcement Class III Ongoing

    Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.

    Recall: Z-0093-2025 · Reported October 23, 2024

    Enforcement

    Recall Number
    Z-0093-2025
    Event ID
    95159
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2024
    Initiation Date
    July 16, 2024
    Classification Date
    October 16, 2024
    Address
    11800 Sw 147th Ave, Miami, FL, 33196-2500, United States

    Description

    Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.

    Reason

    Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.

    Code Info

    UDI/DI 10837461002611, Lot Numbers: 432-24 and higher

    Distribution

    worldwide

    Quantity

    5589 units