BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported March 25, 2026

    Enforcement

    Recall Number
    Z-1586-2026
    Event ID
    98441
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hologic, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2026
    Initiation Date
    February 18, 2026
    Classification Date
    March 19, 2026
    Address
    10210 Genetic Center Dr, N/A, San Diego, CA, 92121-4362, United States

    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.

    Code Info

    Lot Code: The Aptima HPV Assay Kit Part Number 303585, Master Lot 929785 contains one Refrigerated Box (PN 302883) and one Room Temperature Box (PN 302885). The following are the UDI number for each box: UDI Number for PN 302883: 15420045500051 UDI Number for PN 302885: 15420045500068

    Distribution

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

    Quantity

    306