BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated February 9, 2026

    Recall

    Recall Number
    Z-1565-2026
    Event Number
    98400
    Firm
    Abbott Diagnostics Scarborough, Inc.
    FEI Number
    1221359
    Product Code
    OZE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 9, 2026
    Posted
    March 13, 2026
    Address
    10 Southgate Rd, Scarborough, ME, 04074-8303

    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.

    Action

    On or about February 9, 2026 Product Removal Notice letters were sent to customers and distributors. Actions to be taken: " Quarantine and discontinue use of any remaining inventory of the impacted lot. " Count how many unused kit boxes (24 tests / 1 kit box) of remaining impacted inventory require replacement. " Complete and return the Customer Acknowledgment Form (Form must be fully completed, signed and returned to receive replacement product). " Complete the Customer Request for Replacement Product Form. " Customer Service will arrange replacement product and return of your product. " Retain this letter for your records. forward this notice to those you have further distributed or transferred product to.

    Distribution

    US Nationwide distribution.

    Quantity

    111984 units