Hologic, Inc. recalls Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima

Recalled March 25, 2026 · FDA recall Z-1586-2026 · Hologic

Hazard

Due to product exhibiting potential to generate either invalid or false negative results. · FDA Class II

Units

306

Sold at

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

Description

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

Product

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

Manufacturer(s)

Hologic, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →