BEUDAMED
    FDA Enforcement Class II Ongoing

    Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable

    Recall: Z-1565-2026 · Reported March 25, 2026

    Enforcement

    Recall Number
    Z-1565-2026
    Event ID
    98400
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Diagnostics Scarborough, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 25, 2026
    Initiation Date
    February 9, 2026
    Classification Date
    March 13, 2026
    Address
    10 Southgate Rd, N/A, Scarborough, ME, 04074-8303, United States

    Description

    Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable

    Reason

    It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

    Code Info

    List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;

    Distribution

    US Nationwide distribution.

    Quantity

    111984 units