BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes. Component: No, not a component

    Recall: Z-1948-2025 · Initiated March 24, 2025

    Recall

    Recall Number
    Z-1948-2025
    Event Number
    96870
    Firm
    Ortho-Clinical Diagnostics, Inc.
    FEI Number
    1000136573
    Product Code
    OZZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 24, 2025
    Posted
    June 11, 2025
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    Brand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes. Component: No, not a component

    Reason

    It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.

    Action

    On May 6, 2025, URGENT PRODUCT CORRECTION NOTIFICATION letters to customers. REQUIRED ACTION " Do not report Bordetella parapertussis (BPP) positive results when testing with the affected lot numbers. " Use the Solana Bordetella Complete Assay only for reporting Bordetella pertussis (BP) results and negative Bordetella parapertussis (BPP) results only when using the affected lots, as they are not affected. " Review the content of this communication with your Medical Director and retain this letter for your laboratory. " Complete the enclosed Confirmation of Receipt form no later than May 14, 2025. Contact Information We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-874-1517 or [email protected].

    Distribution

    Please see the attached list "Consignee List_CL2025-120." Note: This file contains a specific tab, titled Shipping Summary, which contains the US and ex-US shipping summary. One (1) Distributor was affected. The other four(4) Distributors were sent the notification for information only. QuidelOrtho sent the notification to their consignees because QuidelOrtho drop-shipped this product to their 31 consignees (Included in the Medical Facility total below).

    Quantity

    952 units