BEUDAMED
    FDA Enforcement Class II Ongoing

    Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020

    Recall: Z-2337-2025 · Reported August 27, 2025

    Enforcement

    Recall Number
    Z-2337-2025
    Event ID
    97315
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mckesson Medical-Surgical Inc. Corporate Office
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2025
    Initiation Date
    July 30, 2025
    Classification Date
    August 18, 2025
    Address
    9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, 23233, United States

    Description

    Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020

    Reason

    Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.

    Code Info

    Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers

    Distribution

    US Nationwide distribution in the state of Georgia.

    Quantity

    5 kits