BEUDAMED
    FDA Recall Open, Classified

    Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No

    Recall: Z-1574-2025 · Initiated March 4, 2025

    Recall

    Recall Number
    Z-1574-2025
    Event Number
    96500
    Firm
    Abbott Diagnostics Scarborough, Inc.
    FEI Number
    1221359
    Product Code
    QWR
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    March 4, 2025
    Posted
    April 15, 2025
    Address
    10 Southgate Rd, Scarborough, ME, 04074-8303

    Description

    Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Description: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets Component: No

    Reason

    the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

    Action

    On March 4, 2025 PRODUCT REMOVAL NOTICE letters were sent to distributors. Necessary Actions to be Taken by Distributor: 1. If you have impacted inventory held in stock, then: "Immediately quarantine impacted product per your local procedure. "Complete and return the Distributor Acknowledgment Form (Form must be completed, signed and returned to receive replacement product). "Contact Customer Service to arrange return of your product by Abbott. 2. If you have forwarded the product listed above to others within your distribution network, then: "Inform them of this Product Removal Notice and provide to them a copy of this notice and request they take the necessary action. 3. If you have forwarded the impacted product to your customers, then: "Provide customer list to Abbott based on the product information in Appendix II as outlined in the distribution agreement within 48 hours of receipt of this Product Removal Notice. "Abbott will notify customers of this Product Removal Notice. 4. If you do not have any inventory of the impacted lot(s), then: "All product lots not identified in Appendix I can continue to be used. If you have questions regarding this information, U.S. Customers please contact Sedgwick at 1 888 671 8858 (available 8am 6pm EST, Monday - Friday). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online (http://www.fda.gov/MedWatch/report.htm), by mail (http://www.fda.gov/MedWatch/getforms.htm), by phone (1-800-332-1088), or by fax (1-800-FDA-0178). If you have experienced any patient or user injury associated with this Removal Notice, please immediately report the event to your local area Customer Service. ****Update 05/08/2025**** On April 29, 2025 Updated PRODUCT REMOVAL NOTICE letters were sent to distributors notifying of additional lots that were included in the recall.

    Distribution

    US Nationwide distribution.

    Quantity

    2,164,872 eaches