BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2337-2025 · Initiated July 30, 2025

    Recall

    Recall Number
    Z-2337-2025
    Event Number
    97315
    Firm
    Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233
    FEI Number
    3004386693
    Product Code
    GTY
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    July 30, 2025
    Posted
    August 18, 2025

    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.

    Action

    McKesson notified consignees on about 07/30/2025 via overnight mail. Consignees were instructed to immediately examine inventory and quarantine all affected units, complete and return the provided response form, and destroy any affected products. If affected product was further distributed, consignees were instructed to notify their customers.

    Distribution

    US Nationwide distribution in the state of Georgia.

    Quantity

    5 kits