BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No

    Recall: Z-1586-2026 · Initiated February 18, 2026

    Recall

    Recall Number
    Z-1586-2026
    Event Number
    98441
    Firm
    Hologic, Inc.
    FEI Number
    2024800
    Product Code
    OYB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 18, 2026
    Posted
    March 19, 2026
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362

    Description

    Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No

    Reason

    Due to product exhibiting potential to generate either invalid or false negative results.

    Action

    On 02/18/2026, the firm sent via FedEx an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter to customers informing them that Hologic has identified that the Aptima HPV Assay kits from ML 929785 exhibit the potential to generate either invalid results for samples and calibrators or false negative results for low analyte samples when reagents are not used on the day of reconstitution. Customers are instructed: 1. Discontinue use of the Aptima HPV Assay kits from ML 929785. 2. Segregate and count the number of affected product on-hand and dispose according t the local guidelines and regulations. 3.Fill out the Customer Response Form using the link https://iqvia-response.my.site.com/mt/fca?cid=hpv-929785 4. Hologic will process and ship the replacement kits For Questions or concerns, contact Hologic Technical Support at +1 888-484-4747 or +1 858-410-8511 during hours 5 am to 5 pm PT or by email at [email protected]

    Distribution

    U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.

    Quantity

    306